The State of FDA Review Times, 2026
What 175,812 clearance decisions since 1976, and 2,017 so far this year, say about how long the 510(k) pathway really takes. Computed entirely from the primary record.
A backlog arrived, and a backlog left.
The median tells a calm story: between 119 and 144 days every year for a decade. The 90th percentile tells the true one. In 2022 the slowest tenth of applicants waited 399 days or more, and one in eight clearances took over a year. That was the pandemic backlog working through the system.
The recovery is complete, and then some. The 2025 and 2026 tail (267 and 268 days at the 90th percentile) is the thinnest in the record's modern era, and the share of clearances waiting more than a year has fallen from 12% at the peak to 2% today.
| Year | Median | 90th percentile | Over one year |
|---|---|---|---|
| 2020 | 123 days | 300 days | 4% |
| 2021 | 137 days | 343 days | 8% |
| 2022 | 144 days | 399 days | 12% |
| 2023 | 139 days | 365 days | 10% |
| 2024 | 131 days | 272 days | 4% |
| 2025 | 127 days | 267 days | 2% |
| 2026 (to Aug) | 132 days | 268 days | 2% |
The fastest lane is the one almost nobody takes.
Since 2024, the pathway you file under has mattered more than almost anything else about your submission:
| Route | Clearances since 2024 | Median days |
|---|---|---|
| Traditional 510(k) | 6,867 | 147 |
| Abbreviated 510(k) | 98 | 123 |
| Special 510(k) | 1,268 | 29 |
| Third-party review | 154 | 27 |
1.8%
That is the share of recent clearances that went through an FDA-accredited third-party review organization, at a 27-day median, five times faster than the Traditional route. Eligibility is limited to certain device types, but for teams that qualify, it is the most underused acceleration in the program.
Orthopedics moves in 90 days. Anesthesiology waits 221.
Median days to decision by review specialty, clearances since 2024 (minimum 100 decisions):
Your product code is your clock.
The extremes among product codes with at least 25 clearances since 2024, by average days to decision:
Every product code has its own distribution. The estimator renders it for any code in the record, free.
How these numbers were made.
Source: FDA 510(k) releases via openFDA, complete record 1976 to the August 22, 2026 weekly refresh. Days to decision is the FDA-reported interval from date received to decision date. Medians and percentiles computed per calendar year of decision; pathway, specialty and product-code cuts cover January 2024 through August 2026. Product-code extremes require 25 or more clearances. The record updates every Monday; this report is a fixed snapshot.
Cite this report
Atlas by Auro, “The State of FDA Review Times, 2026.” atlasbyauro.com/fda/state-of-review-times-2026. Data through Aug 2026.
Journalists and researchers: the underlying record is queryable free of charge, and we answer methodology questions at support@atlasbyauro.com.
The averages are interesting. Yours is decisive.
Type your product code and see the real distribution for your device family, from the same record this report is built on.