Key data-status facts first: the official openFDA Device 510(k) page says the dataset updates monthly, and a recent official snapshot said the API coverage ran from 1976 through 2026-06-29; when the live endpoint was opened on July 15, 2026, it reported last_updated = 2026-07-06 and 175,507 total records. FDA’s downloadable 510(k) files page also says its releasable 510(k) files are replaced monthly, usually on the 5th of each month. That makes it likely that, if the service is operating normally, the August 11, 2026 observation will include the July 2026 decisions. (open.fda.gov)

For throughput, I tried not to overreact to the prompt’s staffing language. FDA’s 2025 CDRH annual report says the center was on track to meet key 510(k) review-timeline targets despite resource challenges, and its 2026 outlook says CDRH intended to sustain premarket momentum while adapting to staffing changes. The official FY2026 Q2 MDUFA dashboard page says those dashboards reflect submissions and actions through March 31, 2026, so there is evidence of active ongoing performance monitoring rather than a documented throughput collapse. (fda.gov)

My quantitative base rate uses official FDA cohort data for clearances. An FDA MDUFA report for the completed FY2023 510(k) cohort shows 3,686 accepted 510(k)s and 3,106 SE decisions; that implies a completed-cohort clearance conversion rate of 0.8426478567552903. A later official FDA metrics table reports 3,543 accepted 510(k)s in FY2025. Applying the FY2023 completed-cohort conversion rate to the FY2025 accepted volume gives about 2,985.5 annual clearances, and multiplying by 61/365 to approximate the June 1 through July 31 window gives about 498.95 clearances. (fda.gov)

I then adjusted slightly upward from that mechanical 499 estimate to a central forecast around 505. The reason for the nudge up is that official FDA materials still describe 510(k) performance as on track, and the public openFDA coverage already reaches June 29 rather than showing an obvious stalled update. I did not move the estimate much higher because staffing changes, ordinary month-to-month seasonality, and monthly posting noise could still pull the realized August 11 count downward or upward by several dozen. My final judgment is therefore a distribution centered near 505 clearances, with most probability mass in roughly the mid-400s to high-500s. (fda.gov)

The probability code encodes that view as a mildly downside-skewed mixture distribution centered a little above 500 and then discretizes it onto the 202 requested bins.

I estimate the final August 11, 2026 observed count at 590.

The structural starting point is that the relevant source is the openFDA Device 510(k) clearances API, which is updated monthly and indexed by fields including decision_date; the openFDA field reference lists substantial-equivalence decision codes, so using historical clearance counts is the right analogue here. FDA’s downloadable 510(k) files page also says the source files are replaced monthly, usually on the 5th of each month, and the openFDA status page showed the device/510k endpoint as OK with a last-updated date of 2026-06-29 when crawled. (open.fda.gov)

For the current level, the best observable anchor is recent monthly clearance volume. Using FDA public-file summaries, 2026 monthly clearances through June were 236, 215, 283, 312, 276, 306, for a Jan–Jun total of 1,628. The same source explicitly notes that July 2026 data is incomplete now and that full July data should be available after the August 6, 2026 sync. Historical June/July pairs were 301/251 in 2023, 260/247 in 2024, and 294/281 in 2025. (510kdatabase.net)

Those histories imply a July that is usually a bit below June, but not dramatically so in the last two years. I combined four simple models built from those cited monthly counts: (1) a July-to-first-half seasonality model, which gives roughly 272 for July 2026; (2) a July-to-April-through-June seasonality model, which gives roughly 284; (3) a year-over-year growth model using 2026 vs. 2025 Jan–Jun totals, which gives roughly 285; and (4) a recent June-to-July ratio model using 2024–2025 only, which gives roughly 292. Averaging those puts July around 284, and adding the already-observed June level of 306 implies a two-month total around 590. This arithmetic is my own calculation from the cited monthly counts. (510kdatabase.net)

I do not lean hard into a bearish staffing-collapse story. FDA’s CDRH Annual Report 2025 says that, despite resource challenges, the center was on track for key review-timeline targets in 2025, including the 510(k) substantive-interaction and decision goals; for 2026, CDRH said it intended to sustain premarket momentum while strengthening resilience to staffing changes. That argues for some caution, but not for assuming a sharp throughput break by July 2026. (fda.gov)

The main uncertainty is not June; it is (a) where July lands inside the recent 270s-to-low-290s range, and (b) a small source-timing risk because resolution depends on the exact Aug. 11 observation. Since the FDA source files are usually refreshed around the 5th and the current 2026 clearance page says full July should be available after the Aug. 6 sync, I infer that a fully updated July is the dominant case by Aug. 11. I still leave a small residual probability on lower outcomes to cover sync lag, indexing quirks, or openFDA/public-file mismatches. (fda.gov)

So my final forecast is centered near 590, with most probability mass in the high 560s through low 610s, and only a small tail assigned to much lower anomaly cases. (510kdatabase.net)

I treated this as a short-horizon operational-throughput forecast, with the key wrinkle being that the question resolves on the openFDA API as seen on August 11, 2026 rather than on the underlying decision letters themselves. The official openFDA 510(k) overview says the API is updated monthly, and FDA’s downloadable 510(k) files page says the source files are replaced monthly, usually on the 5th. The raw openFDA endpoint also showed last_updated = 2026-07-06 when queried. That makes it likely that by August 11, 2026 there will have been one more monthly refresh, so July 2026 decisions should mostly be present in the API rather than still missing for timing reasons. (open.fda.gov)

For scale, I used recent official FDA MDUFA throughput numbers as anchors, while being careful not to treat them as identical to the resolution metric. In the November 22, 2024 MDUFA V performance report snippet, FDA reported for FY2023: 3,687 accepted 510(k)s, 3,217 MDUFA V decisions, and 3,078 SE decisions. Another official FDA snippet shows FY2024 at 3,479 accepted 510(k)s. Those are not the same thing as the openFDA count of API records in a date window, but they do establish that recent 510(k) activity has been running at a low-thousands-per-year scale. (fda.gov)

Converting those anchors to a 61-day June 1-July 31 window gives a useful range. If I use the FY2023 SE-decision anchor (3,078/year), a flat-through-the-year conversion gives about 514 decisions in 61 days. If I instead use the broader FY2024 accepted-volume anchor (3,479/year), the analogous conversion is about 581. I put more weight on the lower figure, because the question resolves on cleared 510(k) records in openFDA rather than on accepted submissions or broader workload, and FDA’s dashboard footnotes explicitly warn that some dashboard/workload counts differ from report counts and that third-party handling differs across metrics. (fda.gov)

For the current-state adjustment, I did not assume a dramatic 2026 collapse or surge in output. FDA’s quarterly MDUFA dashboard pages say the quarterly dashboards reflect actions through March 31, 2026, and the 510(k) quarterly dashboard page was current as of March 31, 2026. That supports a view that the program was still functioning at normal large scale entering Q2/Q3 2026, even though the exact monthly pace can wobble. Because today is July 15, 2026, only the second half of July is still unresolved; that limits how far the final June-July total can move away from its baseline unless July proves highly unusual. My inference is therefore that the most likely outcome is in the low-to-mid 500s, not something radically lower or higher. (fda.gov)

My final center is 542 records. Conceptually, that is a weighted blend of the roughly 514 implied by recent SE-decision scale and the roughly 581 implied by broader recent 510(k) volume, with extra uncertainty for month-to-month seasonality, business-day clustering, and the possibility of modest API backfill/noise around the August refresh. I encoded that as a discretized normal distribution with mean 542 and standard deviation 48, which implies an approximate 80% interval of 481-603 and a 90% interval of 463-621. This last step is my modeling judgment, not an FDA-published range. (fda.gov)

I treated this as a forecast for the openFDA 510(k) endpoint’s total decision-date records in the June 1, 2026 through July 31, 2026 window, because the resolution explicitly uses the API’s total-results count for that date filter. openFDA documents the device 510(k) endpoint, lists decision_date as a searchable field, and explains that query results include a total count in meta.results.total; the live endpoint showed last_updated = 2026-07-06 when I checked. (open.fda.gov)

Publication-lag risk looks modest. FDA says the downloadable 510(k) files are replaced monthly, usually on the 5th of each month, and the FDA 510(k) final-decisions database showed an early-July refresh in current official materials. Because resolution is on August 11, 2026, well after the expected early-August refresh, the observed count should usually include the full July 2026 decision set unless there is an unusual posting delay. (fda.gov)

For the level of the count, I used recent FDA 510(k) workload as the main base rate. In FDA’s annual general metrics, CDRH reported 3,761 accepted 510(k)s in FY 2023, 3,529 in FY 2024, and 3,543 in FY 2025. The same table shows FY 2023 had 3,322 MDUFA V decisions plus 437 non-MDUFA decisions and FY 2024 had 3,071 MDUFA V decisions plus 427 non-MDUFA decisions, meaning closed-decision totals were 3,759 and 3,498 respectively—very close to accepted counts. That makes accepted volume a reasonable proxy for eventual decision-date record volume in a steady state. (fda.gov)

I then translated those annual figures into two-month baselines. Using FY 2023-2025 accepted counts gives a two-month average of 601.8333333333334. Using only FY 2024-2025, which better reflects the current regime, gives 589.3333333333334. Using the entire endpoint total of 175,507 records spread over about 50.5 years gives a much longer-run two-month average of 579.2310231023102. A weighted blend of those three anchors gives 591.0628712871287, which I use as the core mean before adding short-run uncertainty. (api.fda.gov)

I did not apply a large extra downward adjustment for reporting lag or an imminent collapse in throughput. FDA’s current public materials show quarterly MDUFA reporting continuing through FY 2026, and current database pages already include multiple July 1, 2026 510(k) decisions, which is consistent with the system continuing to post decisions on schedule. I still allow moderate dispersion for month-to-month operational noise, possible staffing-related effects, and ordinary calendar variation. (fda.gov)

My final forecast is therefore centered at about 591 records, with a deliberately wider spread than the recent annual base rates alone would imply. In the code above I encode that as a normal distribution with mean 591 and standard deviation 55, discretized into the required bins. That corresponds roughly to a 50% interval of about 554 to 628 and a 90% interval of about 501 to 681. My single best point estimate is 591.

The openFDA Device 510(k) endpoint explicitly includes receipt and decision dates, is updated monthly, and the current endpoint metadata shows coverage through 2026-06-29 with 175,507 total records and last_updated 2026-07-06. FDA’s downloadable 510(k) files are replaced monthly, usually on the 5th, and the FDA 510(k) searchable database showed Database Updated 07/13/2026. So the mechanics of the source strongly support the idea that an August 11, 2026 observation should contain the full July posting rather than only a partial month. (open.fda.gov)

For a base rate, I used recent FDA 510(k) throughput. FDA’s MDUFA center-level metrics show FY2024 with 3,462 accepted 510(k)s, 3,023 MDUFA V decisions, and 431 non-MDUFA decisions; FY2025 shows 3,876 accepted, 3,045 MDUFA V decisions, and 303 non-MDUFA decisions. That is a recent annual decision flow in roughly the 3.35k-3.45k range. Annualizing that to a 61-day June-plus-July window gives about 560-577 decisions, and a 3.35k annual pace scaled to 43 federal business days gives about 574. Those calculations point to a natural starting point in the high 500s. (fda.gov)

Current-state data do not suggest a throughput collapse. As of 12/31/2025, CDRH had 563 accepted FY2026 510(k)s and only 34 MDUFA V decisions; by 3/31/2026 that had risen to 1,510 accepted, 369 MDUFA V decisions, and 11 non-MDUFA decisions. The same 3/31/2026 report shows an average 52.56 FDA days to substantive interaction and 98.66% of MDUFA V decisions within 90 FDA days. My read is that this looks more like a normal pipeline ramp than a severe review-capacity breakdown, though it still leaves room for some staffing-related softness. (fda.gov)

Putting that together, I center the forecast at 578. That is slightly above the plain 61-day calendar-rate baseline because June-July 2026 contains 43 federal business days and because the latest published performance metrics still look strong, but I keep a fairly wide spread to allow for batching, month-to-month seasonality, and any staffing effects that were not yet visible in the March data. I encode that uncertainty as a negative-binomial distribution with mean 578 and standard deviation 62, which puts most of the mass roughly from the low 500s to the mid 600s while still allowing materially lower or higher outcomes. This is an inference from the recent annual-flow base rates and the March 2026 performance snapshot, not a direct FDA-reported forecast. (fda.gov)

How many 510(k) medical-device clearances will the FDA’s openFDA Device 510(k) dataset list with a decision date between June 1, 2026 and July 31, 2026 (inclusive), as observed on August 11, 2026?

• My most likely prediction for the number of 510(k) medical-device clearances is 504.02, with a 50% chance of falling between 443.73 and 559.30.
• Historical data shows a steady annual rate of 3,000 to 3,500 clearances, making a two-month total of roughly 500 records the baseline expectation.
• Recent openFDA database increments (+51 records in one week) suggest a current monthly run-rate of approximately 220, or 440 for the two-month period.
• CDRH leadership has remained stable under Director Michelle Tarver, providing operational continuity despite broader leadership flux at the FDA.
• Significant agency-wide staffing shortages (over 3,000 departures in the last year) present a persistent risk to review throughput.
• The openFDA ‘beta’ status and historical update suspensions introduce a possibility of reporting lags, where July 2026 decisions might not be fully reflected by the August 11 observation date.

Key figures

Historical context

The 510(k) pathway has been the primary route for medical device market entry in the U.S. since 1976. Historically, the FDA CDRH processes approximately 3,000 to 3,500 510(k) clearances annually. Under the Medical Device User Fee Amendments (MDUFA V), enacted in 2022 and running through 2027, the FDA has established strict performance goals for review timelines, supported by user fees (standard fee of $21,760 in FY 2024). In March 2025, the openFDA platform notably suspended updates for a period, highlighting the potential for technical lags in its ‘beta’ datasets. Recent organizational changes include the appointment of Michelle Tarver as CDRH Director in October 2024, following long-time director Jeffrey Shuren. Despite agency-wide leadership turnover in 2025 and 2026, the CDRH has been characterized in professional news as more stable than the drug and biologic centers.

Tailwinds

• CDRH leadership is reported as ‘steady’ and has avoided the leadership turnover affecting other FDA centers.
• The FDA is actively onboarding approximately 2,200 new workers, which may help clear administrative backlogs in mid-2026.
• The agency is increasingly using AI to sort information and draft deficiency letters, which could potentially improve review efficiency and decision volumes.
• Historically, lumpy data reporting often results in ‘catch-up’ months where a higher volume of clearances is posted to the database simultaneously.

Headwinds

• The FDA experienced a net loss of over 3,000 employees between June 2025 and June 2026, leaving many review positions vacant or filled by less experienced staff.
• On June 5, 2026, the FDA issued guidance exempting 13 specific product codes from 510(k) requirements, which may slightly reduce the total volume of clearances.
• Reports indicate remaining FDA staff are overworked and under pressure to meet goal dates, which may lead to more ‘Complete Response Letters’ to buy review time instead of final clearances.
• OpenFDA is a ‘beta’ service with a history of update suspensions, creating a risk that the July 2026 data will not be fully indexed by the August 11 observation date.

Detailed reasoning

My prediction is primarily anchored on the historical base rate of FDA 510(k) clearances and recent high-frequency data from the openFDA database. Historically, the FDA clears between 3,000 and 3,500 510(k) submissions annually, which translates to a two-month average of roughly 500 to 580 clearances. Recent data from the openFDA API showed a total record count of 175,507 as of July 6, 2026, with an increase of 51 records over the preceding week. While weekly increments can be ‘lumpy’ due to batch processing, this specific snapshot suggests a monthly run-rate of approximately 220 records, or 440 for the two-month forecast window.

I weighted the CDRH’s operational stability heavily. News reports from June and July 2026 indicate that while the broader FDA has faced significant leadership turnover (Acting Commissioners and Director vacancies in CDER and CBER), the Center for Devices and Radiological Health (CDRH) has remained ‘steady’ under Director Michelle Tarver. This stability suggests that the center is likely to maintain its standard review throughput despite agency-wide staffing pressures.

However, I applied a modest downward adjustment to account for staffing shortages. The FDA lost over 3,000 employees between mid-2025 and mid-2026, and as of June 2026, only about 600 of the 2,200 authorized replacement positions had been filled. This resource gap likely increases the administrative burden on existing reviewers, potentially leading to ‘Reviewer Clock’ extensions or more frequent ‘Complete Response Letters’ to buy time, both of which would marginally reduce the volume of finalized clearances in any given two-month period.

A critical component of this forecast is the reporting mechanics of the openFDA dataset. The resolution requires the count as observed on August 11, 2026. Because FDA CDRH typically replaces its downloadable files and refreshes its searchable database around the 5th of each month, the August 11 observation date should catch the full June and July decision batches. Nevertheless, because openFDA is explicitly labeled as a ‘beta’ service and has a history of update suspensions (most recently noted in March 2025), I have incorporated a ‘reporting lag’ scenario into the lower tail of the distribution. In such a scenario, the July data might only be partially posted by the cutoff, resulting in a significantly lower count (roughly 300-350) that primarily reflects June decisions.

I considered the June 5, 2026 guidance exempting 13 low-risk product codes from 510(k) requirements. While this reduces the pool of required submissions, the impact on clearances within the June-July 2026 window is likely minimal. Most clearances issued in those months would stem from submissions made 3 to 6 months prior, before the exemption was enacted. Consequently, this factor acts as a very weak headwind.

The resulting most likely value of 504 reflects a balance between the historical norm (mid-500s) and current staffing/throughput signals (mid-400s), with the 50% HDI representing the expected variance in monthly administrative batching.

Key uncertainties

• Technical Stability: If the openFDA API experiences an update suspension similar to March 2025, the count could be artificially low or zero.
• Batch Processing: FDA data releases are often lumpy; if the ‘July’ update happens after August 11, the resolution count will only reflect June clearances.
• Staffing Rebuild Speed: If the 600+ new hires are onboarded and productive faster than expected, it could trigger a surge in cleared applications.
• Regulatory Discretion: Sudden shifts in enforcement discretion or new exemptions could change the volume of devices requiring a 510(k).

Conclusion

• Expect a volume of approximately 504 clearances for the June-July 2026 window, which aligns with historical base rates and recent weekly data updates.
• Monitor the openFDA API status in early August 2026; any suspension of updates or technical ‘beta’ instability could significantly lower the observed count by excluding July decisions.
• Use the 50% interval of 443 to 559 as the primary planning range, noting that organizational stability at CDRH provides a floor against broader agency-wide leadership turnover.

Question: how many FDA 510(k) decisions will openFDA report for decision_date between 2026-06-01 and 2026-07-31 on the openFDA 510(k) endpoint observed 2026-08-11? The teams agree this is an openFDA ingestion/counting question, not a clinical outcome, and anchor on a secondary FDA-file-based proxy that already shows June 2026 = 306 clearances. Historical June+July totals in that proxy (2022–2025) average ≈542 with July typically ≈0.9× June, so conditioning on June=306 implies a July proxy ~275–285 and a June+July center in the high‑500s. Forecasters modestly upweight openFDA/BTIG-style counting differences (tens of records) and thus center the likely openFDA resolution just under 600 to around 585–598, with meaningful but not huge dispersion. All teams also note a small “low-mode” risk that openFDA hasn’t ingested July by Aug 11, leaving a June-only count near ~306; true extreme low/high outcomes are judged effectively negligible. Key operational caveats: openFDA ingestion timing and methodology differences vs. 510kDatabase/BTIG can shift counts by a few dozen records, and recent FDA staffing news is treated as background context rather than evidence of an imminent collapse in decisions.

Forecast and Reasoning

Forecast: Probability distribution:

• 1.00% chance of value below 350.0
• 5.00% chance of value below 450.0
• 10.00% chance of value below 510.0
• 20.00% chance of value below 545.0
• 30.00% chance of value below 565.0
• 40.00% chance of value below 585.0
• 50.00% chance of value below 600.0
• 60.00% chance of value below 615.0
• 70.00% chance of value below 635.0
• 80.00% chance of value below 660.0
• 90.00% chance of value below 695.0
• 95.00% chance of value below 730.0
• 99.00% chance of value below 800.0

Forecast Reasoning

We are forecasting the openFDA device/510k endpoint’s total-results count for decision_date in 2026-06-01 through 2026-07-31, as it will appear on 2026-08-11 23:59 UTC.

Key drivers and evidence from the analyst set:

• Recent annual totals (~3,100–3,300/year) imply a baseline of ~520–550 for a generic two-month window, before conditioning on 2026-specific data.
• Multiple analysts cite (via either direct API querying or secondary aggregations of FDA monthly files) that June 2026 alone is unusually high, roughly in the 306–325 range. This is the most important anchor because half the target window (June) is already effectively known.
• July is the main uncertainty. Recent historical July counts appear to cluster around the mid-240s to low-280s, with some chance of a higher month if 2026 throughput is elevated. Combining June (~315) with a typical July (~270–290) yields a central estimate around ~585–605.

Uncertainties I explicitly incorporate:

• Definition/coverage mismatch risk: some sources may count “cleared/granted” slightly differently than what openFDA returns under its 510(k) endpoint, which could shift totals upward by a few percent.
• Operational/data-pipeline risk: while the design of the question expects the July monthly refresh to have posted by Aug 11, a small probability remains that openFDA is behind on incorporating late-July decision dates even if the endpoint is reachable (this creates a left-tail scenario closer to “June-only” or “June + partial July”). This is why my p1–p5 are meaningfully lower than a simple throughput-variance model would suggest.

Overall synthesis: I place the median at 600, with the bulk of probability between roughly the mid-500s and upper-600s, and small but non-zero mass for a substantial undercount (data lag) and for an unusually high July (upper tail).

An amateur forecast would often (a) use annual_total/6 and ignore that June 2026 is already observed to be high, and/or (b) assume the Aug 11 snapshot must be complete and thus understate the left-tail risk from data-refresh slippage. My forecast conditions on the June 2026 level cited by multiple analysts, uses recent June/July seasonality to project July, and adds a small mixture-style left tail for the possibility that the dataset is not fully refreshed for late July even if the API is up. This should improve calibration versus a single-point estimate or a too-narrow normal approximation. Confidence: moderate (main remaining uncertainty is July volume and any openFDA-vs-source counting mismatch).

Forecast rationale (numeric):

— Iteration 1 — The forecasts converge on a mid-500s to low-600s count of 510(k) clearances in the openFDA Device 510(k) dataset for June 1–July 31, 2026, as observed on August 11, 2026.

Key reasoning patterns

• Historical throughput as the main anchor: The estimates are built from recent annual clearance rates, translated into an expected two-month total.
• Two-month window math: Typical monthly clearance pace is treated as roughly mid-200s to mid-300s per month, implying a June-plus-July total around 530–700 if both months are fully captured.
• Snapshot timing matters a lot: A major source of uncertainty is whether the August 11 openFDA snapshot fully includes July decisions. If the dataset update is delayed or July ingestion is incomplete, the observed count could be much lower, closer to June-only levels.
• Operational/headwinds adjustment: Some downward adjustment is applied for possible CDRH staffing or throughput reductions in 2026, which would temper the naive historical extrapolation.
• Broad uncertainty bands: The reasoning explicitly allows for large tail risk from batch posting, data latency, and incomplete ingestion, rather than assuming a tight historical range.

Areas of consensus

• The most likely outcome is well above 300 and probably around 500–600 if the dataset is reasonably current.
• The biggest uncertainty is not the underlying clearance rate alone, but whether July data has fully posted by August 11.
• The distribution is asymmetric, with a meaningful chance of a much lower count if the snapshot lags.

Main differences in emphasis

• One line of reasoning is more conservative, centering near the mid-500s.
• Another is slightly higher, near 600+, using a stronger monthly rate assumption.
• A more aggressive naive extrapolation reaches ~700, but this is then pulled down to account for delayed posting and possible 2026 slowdown.

Bottom line

The collective view is that the observed dataset count will most likely land in the mid-500s, with substantial downside risk if the August 11 snapshot has not yet fully incorporated July 2026 clearances.

— Iteration 2 — The forecasts converge on a simple anchor: the reported 1,669 510(k) clearances through June 2026, which implies roughly 278 clearances per month. Extending that pace across June and July points to a total in the mid-500s, with central estimates clustered around about 555–570.

The biggest source of uncertainty is not the underlying clearance rate, but whether openFDA has fully ingested July 2026 records by the August 11 observation date. A delay in the monthly update could pull the observed count down substantially, potentially toward a June-only or partial-July total in the high-200s to mid-300s. There is also some allowance for modest throughput variation, including possible slowdown from staffing changes, versus a higher-than-normal count if backlog catch-up or stronger processing occurs.

Overall, the shared reasoning is:

• Primary anchor: 1,669 clearances through June 2026
• Expected pace: roughly 278/month
• Likely outcome: mid-500s for June 1–July 31 combined
• Main downside risk: incomplete July ingestion in openFDA by Aug. 11
• Main upside risk: faster-than-average throughput or backlog/backfill effects

— Iteration 3 — The forecasts largely rely on the same framework: estimate a normal monthly 510(k) clearance rate from recent history, then extend it across June and July 2026. That yields a broad expected total in the mid-500s to mid-600s, depending on the monthly baseline used.

Main reasoning patterns

• Historical throughput is the anchor. Each rationale uses recent FDA 510(k) activity to infer a typical monthly volume, then multiplies by two months.
• Timing of the openFDA update is the biggest uncertainty. A major concern is whether the dataset will be fully refreshed by August 11, 2026. If not, some or much of July may be missing, making the observed count look closer to a one-month total.
• Seasonal and staffing factors slightly depress the center. References to 2026 staffing constraints and normal summer variability push the estimate downward a bit from a simple historical extrapolation.
• Wide tails are intentional. The rationales allow for backfills, backlog clearance, broader inclusion of decision codes, or other dataset anomalies, so the distribution is kept broad rather than overly precise.

Where the forecasts agree

• June and July should together produce several hundred clearances.
• The observed count on Aug. 11 may be lower than the eventual true June-July total if openFDA lags.
• The uncertainty is driven more by dataset refresh behavior than by the underlying clearance process itself.

Where they differ

• The main disagreement is the assumed monthly clearance rate:
  • one line of reasoning uses a lower monthly rate, implying a mid-500s two-month total;
  • another assumes a higher monthly rate, implying a low-to-mid-600s total.
• Some treat the outcome as bimodal: either a full two-month count if refreshed, or a much lower partial count if July is not yet indexed.

Overall synthesis

The collective view is that the count should be based on normal June-July clearance volume, but with substantial uncertainty from openFDA indexing latency. The most likely result is a few hundred to around 600-plus entries, with a meaningful downside risk if the August 11 snapshot is incomplete.

Here is a synthesis of the shared reasoning across all the rationales:

Fundamental Clearance Volume and Seasonality The rationales agree that predicting the true number of 510(k) clearances requires accounting for recent volume trends and distinct seasonal patterns. Despite well-documented staffing reductions and elongating review timelines (averaging roughly 156 days), FDA throughput in the first half of 2026 remained robust, showing steady year-over-year growth.

Forecasters anticipate a strong output for June, which historically sees a seasonal spike as the agency pushes to clear mid-year backlogs and finalize the surge of submissions from the prior December. July, however, is expected to experience a regression. Multiple rationales attribute this anticipated July dip to standard seasonal slowing, as well as the specific implementation of the FDA’s new Quality Management System Regulation (QMSR) in February 2026. Because of the 156-day review lag, friction from the February QMSR rollout is expected to temporarily depress the volume of decisions landing in July.

Technical Synchronization and API Lag While the underlying two-month clearance volume is expected to be solid, the most critical factor driving the forecast is the technical risk associated with the openFDA API update schedule. The observation date is set for August 11, shortly after the FDA’s primary monthly data release, which typically occurs around August 5.

The rationales highlight three potential technical outcomes that shape a heavily bimodal distribution:

• Fully Synced: The openFDA pipeline successfully ingests the primary August data drop before August 11, capturing the complete two-month volume.
• Partially Synced: Due to routine administrative delays, clearances granted in the very last days of July miss the early-August database compilation, leading to a minor undercount.
• Failed Sync (Left-Tail Risk): The tight window between the August 5 FDA release and the August 11 observation date causes the openFDA pipeline to miss the July update entirely. If this occurs, the query will strictly return clearances from June, significantly lowering the observed count. Forecasters heavily weighted their lower bounds to account for this systemic ingestion risk.

SUMMARY

Question: How many 510(k) medical-device clearances will the FDA’s openFDA Device 510(k) dataset list with a decision date between June 1, 2026 and July 31, 2026 (inclusive), as observed on August 11, 2026? Final Prediction: Probability distribution:

• 10.00% chance of value below 566.9
• 20.00% chance of value below 588.4
• 40.00% chance of value below 609.15
• 60.00% chance of value below 626.9
• 80.00% chance of value below 648.15
• 90.00% chance of value below 662.15

Total Cost: extra_metadata_in_explanation is disabled Time Spent: extra_metadata_in_explanation is disabled LLMs: extra_metadata_in_explanation is disabled Bot Name: extra_metadata_in_explanation is disabled

Report 1 Summary

Forecasts

Forecaster 1: Probability distribution:

• 10.00% chance of value below 559.4
• 20.00% chance of value below 585.4
• 40.00% chance of value below 609.9
• 60.00% chance of value below 629.9
• 80.00% chance of value below 653.9
• 90.00% chance of value below 669.9

Forecaster 2: Probability distribution:

• 10.00% chance of value below 574.4
• 20.00% chance of value below 591.4
• 40.00% chance of value below 608.4
• 60.00% chance of value below 623.9
• 80.00% chance of value below 642.4
• 90.00% chance of value below 654.4

Research Summary

The research uses the FDA’s recent output as the primary outside-view anchor: historically the FDA issues about 3,100–3,300 510(k) clearances per year (≈259–277/month), but in the first six months of 2026 the FDA granted 1,669 510(k) clearances, an average of 278 per month. Because the forecast window covers two months (June–July 2026), the standard reference-class projection based on the H1 2026 run-rate is 556 clearances.

Operational context cited to explain the elevated run-rate includes significant CDRH staffing churn (≈22% losses in late 2024/early 2025 followed by onboarding >2,000 new staff), an FDA submission acceptance shutdown in Oct–Nov 2025, and lengthening average review times (from ~148 days in 2025 to ~155–156 days in H1 2026). Those factors, plus the roughly five-month review lag, mean a post-shutdown surge of submissions is reaching decision in mid-2026, supporting the higher monthly clearance rate. The research notes no active prediction markets (Polymarket/Manifold) for this question and flags a potential downward variance: the observation date (Aug 11, 2026) could miss a small number of late-July clearances if openFDA’s API reporting lags (the API typically updates in the first week of the month), producing minor undercounting in the dataset.

Sources used:

• FDA openFDA Device 510(k) API: https://open.fda.gov/apis/device/510k/
• FDA Center for Devices and Radiological Health (CDRH): https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health
• Polymarket: https://polymarket.com
• Manifold Markets: https://manifold.markets

(Additional numbered references in the research — e.g., [2], [3], [5], [6], [50], [51] — were cited in the supplied material but no explicit URLs for those citations were provided.)

RESEARCH

Report 1 Research

To forecast the number of 510(k) medical-device clearances between June 1, 2026, and July 31, 2026, the strongest outside-view anchor is the FDA’s output during the first half of 2026.

Base Rates & Quantitative Anchors: Historically, annual 510(k) clearances range between 3,100 and 3,300 (averaging 259 to 277 per month) [5]. Through the first six months of 2026, the FDA granted exactly 1,669 510(k) clearances [2]. This equates to an average of 278 clearances per month [6]. Because the forecast window covers exactly two months (June and July), the standard reference class projection is 556 clearances.

News & Operational Context: The FDA’s Center for Devices and Radiological Health (CDRH) has faced operational turbulence over the last year. In late 2024 and early 2025, the CDRH lost roughly 22% of its staff [3]. In response, they have recently onboarded a massive influx of over 2,000 new personnel [2]. Concurrently, the FDA suffered a submission acceptance shutdown from October to November 2025 [6].

These two factors have resulted in longer average review times (increasing from ~148 days in 2025 to 155-156 days in H1 2026) [6]. Because the average review time is roughly five months, the surge of submissions that immediately followed the late-2025 shutdown is currently reaching the final decision phase throughout mid-2026. This explains why the monthly clearance rate (278/month) is currently running higher than historical averages, despite the institutional friction.

Prediction Markets: There are no active or liquid prediction markets on Polymarket, Manifold, or other platforms regarding FDA 510(k) clearances for this period. Forecasters must rely entirely on the established base rates and operational data.

Key Takeaways for the Forecaster:

1. Anchor: ~556 clearances (based on the 278/mo H1 2026 run-rate).
2. Upward variance: The FDA is highly motivated to clear the late-2025 submission backlog, and the newly expanded workforce may hit its stride in the summer of 2026.
3. Downward variance: The observation date is August 11, 2026. While the openFDA API typically updates in the first week of the month [50], minor reporting lags could result in a small number of late-July clearances not populating the dataset in time for the API query [51].

FORECASTS

R1: Forecaster 1 Reasoning

Conditional on the question not being annulled:

The critic’s main points are valid and change the dispersion more than the central estimate.

What I accept

1. The precise cutoff mechanism remains uncertain.
   The official openFDA overview currently describes the dataset as monthly and reports coverage through June 29, 2026. Separately, the status page reports a June 29 update and 175,456 records, while the dialogue’s live-endpoint metadata reports a July 6 update and 175,507 records. These inconsistencies support revision and ingestion uncertainty, but they do not establish a deterministic one-business-day cutoff. (open.fda.gov)

2. A page-update date is not a record-insertion timestamp.
   June 30 records appearing on pages with July update footers do not prove exactly when those records entered the source extract. The underlying searchable database updates weekly, whereas openFDA updates monthly, so batching can be irregular. (fda.gov)

3. The unexplained 306-versus-325 discrepancy dominates fine adjustments.
   Until the supplied 325-record June query is reconciled by identifier prefix and decision code, it deserves ordinary-case uncertainty of perhaps several to roughly fifteen records. Estimating the exact contribution of July 31 more precisely than that would be false confidence.

4. The tails should be wider.
   My previous mixture attached overly precise weights to modes that have not been calibrated against historical openFDA update cycles. I am increasing probability in both the 430–530 partial-ingestion region and the 690–760 retrospective-revision region.

What I continue to defend

The resolution is a point-in-time data-pipeline result, so materially partial and June-only outcomes require explicit probability. Conversely, complete July absence should remain a small tail event: FDA says its downloadable files are usually replaced around the fifth, leaving roughly six days before the August 11 observation. (fda.gov)

The fallback remains ordinary-to-high rather than a downside scenario. FDA identifies the searchable 510(k) database as weekly, and its surfaced page was updated July 13, making it plausibly fresher than a stale openFDA snapshot. (fda.gov)

Revised synthesis

My approximate ordinary-case calculation is:

• Supplied June API anchor: 325
• Expected June additions/revisions: roughly +5 to +12
• July records visible in the August snapshot after possible batching or truncation: roughly 275–295
• Ordinary-update range: approximately 605–632, centered near 619

Scope uncertainty, weak July throughput and routine truncation pull below that center; fresher fallback data, retrospective additions and a strong July create corresponding upside. The unresolved metadata and scope issues therefore justify a median near 616, but not a sharply concentrated distribution.

Compared with the prior round, I raise the median by two records because the evidence for a reliably downward June 29-style cutoff is weaker than previously presented. I lower the 5th percentile and raise the upper percentiles because partial ingestion and scope rebasing are both less well constrained than the earlier mixture implied.

Updated prediction:
Percentile 0.1: 286.4
Percentile 1: 336.4
Percentile 5: 522.4
Percentile 10: 550.4
Percentile 20: 578.4
Percentile 30: 593.4
Percentile 40: 605.4
Percentile 50: 616.4
Percentile 60: 628.4
Percentile 70: 640.4
Percentile 80: 655.4
Percentile 90: 673.4
Percentile 95: 691.4
Percentile 99: 732.4
Percentile 99.9: 806.4

R1: Forecaster 2 Reasoning

Conditional on the question not being annulled.

What I accept from the critic

The supposed “direct endpoint count” remains approximate. The live API metadata reports 175,507 records and a July 6, 2026 update, while the static endpoint overview still describes coverage only through June 29. This synchronization discrepancy means neither the unofficial mirror nor the overview establishes the exact June/early-July split. (api.fda.gov)

The lower tail should also allow non-monotonic revisions. openFDA explicitly warns that updates can alter old records, so the currently inferred total is not an inviolable floor. (open.fda.gov)

Finally, 33 decisions over July 1–2 are weak throughput evidence. Two potentially batch-heavy days around a holiday should not be extrapolated into a 300-plus July without substantial shrinkage.

What I still defend

I continue to reject mechanically adding another average decision day to June. The static June 29 coverage label is evidently not synchronized with the July 6 API metadata, while the supplied record-level evidence already contains June 30 decisions. Treating June 30 as entirely missing would therefore risk double-counting.

The unrestricted endpoint ontology also remains broader than an ordinary cleared-K count: its schema recognizes K, BK, and DEN prefixes. Because resolution uses a date-only query, the forecast should model the endpoint’s actual records rather than adding a supposedly stable “ontology premium” to narrow third-party clearance totals. (open.fda.gov)

Revised synthesis

My central decomposition is now:

• June contribution: approximately 323–328
• July under full or nearly full ingestion: approximately 284–296
• Primary-mode total: approximately 608–624

I place roughly 93–95% on full or nearly full July ingestion, several percent on materially partial ingestion, and below 1% on little or no progress beyond the current snapshot. FDA’s source files are normally replaced around the fifth of each month, leaving nearly a week before the August 11 observation, although openFDA is a distinct pipeline and therefore retains meaningful failure risk. (fda.gov)

The conflict between the API’s July 6 metadata and the overview’s June 29 label is more suggestive of documentation lag than a known hard data cutoff. Consequently, I would not centrally subtract all July 31 decisions. Instead, I price that possibility through the lower-tail ingestion mixture.

I therefore raise the median only slightly, from 613.4 to 615.4, while widening both tails. The critic’s central recommendation is persuasive; the less accurate contrarian forecast’s slightly higher upper quantiles and lower extreme tail are not sufficiently justified.

Updated prediction:
Percentile 0.1: 351.4
Percentile 1: 465.4
Percentile 5: 540.4
Percentile 10: 570.4
Percentile 20: 589.4
Percentile 30: 599.4
Percentile 40: 607.4
Percentile 50: 615.4
Percentile 60: 623.4
Percentile 70: 632.4
Percentile 80: 642.4
Percentile 90: 654.4
Percentile 95: 667.4
Percentile 99: 697.4
Percentile 99.9: 744.4

Frontier Forecast — Post 616

Modal: 575-700 (50.4%) • frontier aggregate • 6m28s

Interpret Summary

• Reading: strict
• Type: strict
• Window: Count of records in the openFDA Device 510(k) dataset with decision_date between 2026-06-01 and 2026-07-31 inclusive, as queried at 23:59 UTC on 2026-08-11

Resolution sources/checks:

• https://api.fda.gov/device/510k.json: https://api.fda.gov/device/510k.json - Resolver URL extracted mechanically from resolution criteria

Edge cases:

• The openFDA dataset is updated on a monthly cadence — records for July 2026 may not all be posted by August 11, 2026 if the monthly update is delayed beyond the observation date, potentially understating the true count.
• The annulment clause (both sources unreachable) is technically an annulment risk, but source unavailability is very rare; however the question explicitly voids it rather than defaulting to zero, so it is a true annulment risk (not just…
• Decision codes: the criteria say ‘all clearance decision codes that the dataset classifies under a 510(k) decision are included’ — if the dataset contains non-clearance outcomes (e.g. Not Substantially Equivalent decisions) tagged with a…

Frontier Views (5/5)

• frontier_1 - Modal: 575-700 (65.0%)

  • As of 2026-07-15, openFDA shows 358 records for 2026-06-01 to 2026-07-31, with June 2026 essentially complete at 325 and July 2026 preliminarily at 33 due to the monthly update lag (last_updated 2026-07-06).

• frontier_2 - Modal: 575-700 (36.0%)

  • The question asks for the count of openFDA 510(k) records with decision_date in June+July 2026, observed Aug 11, 2026.

• frontier_3 - Modal: 575-700 (50.0%)

  • As of July 6, 2026, the openFDA API reports 325 clearances for June 2026 and 33 for July 2026, for a total of 358. The dataset is updated monthly; historical early-2026 clearance rates range from 217 to 325 (averaging ~280/month).

• frontier_4 - Modal: 449-575 (75.0%)

  • Historical annual totals of 3100-3300 imply ~258-275 clearances per month; 2026 YTD pace is ~278/mo. For the 61-day June-July window this centers on 520-570 records, mapping directly to 449-575 (bin_3).

• frontier_5 - Modal: 575-700 (72.5%)

  • Direct openFDA API queries gave the following decision_date totals: June 2026 = 325 (already observed), plus 20 months of historical monthly data (2024-05 through 2026-06) with mean ≈ 277, median ≈ 282, std ≈ 32. The 2026 monthly trend has been slightly elevated (2026 median ≈ 291 vs 2024-25 median ≈ 280).

Adjudication

• Status

  • 5 non-blocking adjudication note(s); no lane required discounting.

• Guidance

  • All agents used the resolver (openFDA API) correctly for the June–July window and documented plausible historical anchors and update-timing uncertainty. None have the actual Aug 11 resolver snapshot yet, so all forecasts are prior-based and should be rechecked against the openFDA/CSDR database on Aug 11–12.

• Revision

  • Frontier revision skipped: no_selected_adjudicator_reviews.

Final Distribution (discrete bins)

Sources Checked

• Resolver: Resolver URL extracted mechanically from resolution criteria - https://api.fda.gov/device/510k.json
• frontier_1: https://api.fda.gov/device/510k.json?search=decision_date:[20260601+TO+20260731]&limit=1
• frontier_1: https://api.fda.gov/device/510k.json?search=decision_date:[20260601+TO+20260630]&limit=1
• frontier_1: https://api.fda.gov/device/510k.json?search=decision_date:[20260701+TO+20260731]&limit=1
• frontier_1: https://api.fda.gov/device/510k.json?search=decision_date:[20260501+TO+20260531]&limit=1
• frontier_1: https://api.fda.gov/device/510k.json?search=decision_date:[20260401+TO+20260430]&limit=1

wooley_rhino • run 84c92114 • $3.06 • 6m28s

Extracted Percentile Values: {0.1: 265, 1.0: 350, 5.0: 460, 10.0: 505, 15.0: 530, 20.0: 548, 25.0: 560, 30.0: 570, 35.0: 578, 40.0: 585, 45.0: 591, 46.0: 592, 47.0: 593, 48.0: 594, 49.0: 596, 50.0: 597, 51.0: 598, 52.0: 600, 53.0: 602, 54.0: 604, 55.0: 606, 60.0: 614, 65.0: 623, 70.0: 634, 75.0: 645, 80.0: 660, 85.0: 678, 90.0: 700, 95.0: 735, 99.0: 810, 99.9: 920}

Model’s Answer:

Forecasting 510(k) Clearances: June 1 – July 31, 2026

Step one: Anchor to historical data

The most directly relevant data points come from the openFDA API queries for the exact same date window in prior years:

• June 1–July 31, 2024: 515 clearances
• June 1–July 31, 2025: 579 clearances

This represents ~12.4% YoY growth from 2024→2025. Annual totals confirm stability: 3,107 (FY2024), 3,238 (FY2025), 3,326 (FY2023).

Step two: Project 2026 trend

H1 2026 shows 1,669 clearances, approximately 2.5% above H1 2025. This growth rate is slowing but positive. Applying ~2.5% to the 2025 Jun-Jul count: 579 × 1.025 ≈ 593. Monthly averages of ~250-300 clearances × 2 months = 500-600 range, consistent.

Step three: Key risk factors

Factors that could depress the count (low scenario):

• CDRH staffing cuts (~22% reduction), even with partial rehiring, could cause a meaningful slowdown
• Longer review times (~156 days in H1 2026 vs ~148 days previously) may delay decisions into later periods
• Data posting risk: if July clearances haven’t fully propagated to openFDA by August 11, the count reflects only June (~250-320 clearances). However, the resolution criteria explicitly accounts for this by closing the window July 31 to ensure the monthly update posts. I assign ~5% probability to partial/delayed July posting.

Factors that could inflate the count (high scenario):

• Submission volumes remain strong; AI/ML devices alone contributed 84 510(k)s in just Q2 2026
• MDUFA V performance goals maintained; no evidence of systematic breakdown
• Companies not delaying despite higher fees, sustaining pipeline

Step four: Critical assumptions

Assumption A: July 2026 data fully posts to openFDA before August 11. This is likely (~92%) given normal monthly cadence (~5th of following month = Aug 5). Failure would drop the count to ~270-330 (June only). Probability of failure: ~8%.

Assumption B: CDRH staffing disruptions don’t cause a sharp temporary slowdown. Staffing cuts occurred in 2025; partial rehiring noted. Some throughput impact is already baked into the ~156-day average. Severe acute disruption: ~10% probability.

Assumption C: The YoY growth trend (~2.5%) continues into Q2-Q3 2026. The most likely scenario given H1 data, but uncertainty around 2H performance: ~80% probability the count is within ±10% of the central estimate.

Step five: Distribution construction

Central estimate: ~593-600 clearances. Standard deviation based on year-to-year variability (~64 between 2024-2025) and within-period noise: approximately 55-65 clearances. With data posting risk adding a small probability mass around 270-320:

• Low tail (~270-320): ~6-7% probability (data posting failure + partial July coverage)
• Main distribution: centered ~595, SD ~60
• High tail (>750): ~4% probability (surge in AI/ML + backlog clearing)

Percentile .1: 265 Percentile 1: 350 Percentile 5: 460 Percentile 10: 505 Percentile 15: 530 Percentile 20: 548 Percentile 25: 560 Percentile 30: 570 Percentile 35: 578 Percentile 40: 585 Percentile 45: 591 Percentile 46: 592 Percentile 47: 593 Percentile 48: 594 Percentile 49: 596 Percentile 50: 597 Percentile 51: 598 Percentile 52: 600 Percentile 53: 602 Percentile 54: 604 Percentile 55: 606 Percentile 60: 614 Percentile 65: 623 Percentile 70: 634 Percentile 75: 645 Percentile 80: 660 Percentile 85: 678 Percentile 90: 700 Percentile 95: 735 Percentile 99: 810 Percentile 99.9: 920

A monthly public update cycle creates discrete windows that determine which decisions are visible on a given observation date.

Review capacity is governed by staffing and fee‑driven throughput, so output shifts over months rather than days.

June visibility is unusually high relative to recent midsummer baselines, anchoring the two‑month total upward.

Year‑to‑date clearance momentum and historical July patterns imply a substantial July addition under normal reporting.

If the scheduled monthly refresh is ingested before the observation timestamp, July entries will lift the June subtotal toward roughly six hundred total records.

If the refresh is absent or the public feed remains stale, the observed count will stay near the current partial snapshot and be materially lower.

The principal unresolved uncertainty is whether the July refresh has been applied to the public feed by the observation moment, with synchronization lags changing the total by a few dozen.

Secondary sensitivity is an unexpected operational slowdown or reporting‑policy change that would both reduce clearances and delay their appearance, producing a lower tail.

Forecast (median): 579.2668

• June is already strong and mostly “in the bag.” By the last observed update, the dataset already contained 358 decisions up through July 2, suggesting a solid June foundation.
• Historical June–July totals sit in a tight band. Prior years’ combined counts are 560 (2023), 515 (2024), and 579 (2025), so 2026 is expected to land near the middle-to-upper part of that range if July is captured normally.
• The main swing factor is snapshot completeness for late July. The dataset had only advanced to July 2 as of the most recent refresh before the Aug 11 observation, so late-July decisions could be undercounted if the August refresh doesn’t include them yet.
• Throughput signals don’t show a collapse yet. Monthly decision counts through May 2026 look stable (no obvious drop), which supports a “mostly normal” July volume assumption.
• So the distribution skews downward. Under-detection from reporting lag is a bigger risk than overcounting, creating a fatter lower tail—hence the emphasis on keeping some downside probability even with a strong baseline.