FDA 510(k) Review Times by Panel, 2026

Data as of September 19, 2026 · Source: openFDA

FDA took a median of 130 days to clear a 510(k) in the 12 months to September 19, 2026, across 3,289 clearances, counting from receipt to decision. That compares with 123 days in the previous 12 months and 132 days the year before. A quarter of clearances took longer than 224 days. In 2017 the median was 123 days. Over the last 24 months the Clinical Toxicology panel cleared fastest (median 53 days) and the Pathology panel slowest (238 days). Special 510(k)s took a median 30 days against 146 for Traditional.

Headline: median days from receipt to clearance

510(k) review time by year

510(k) review time by review panel

Last 12 months from 2025-09-19; last 24 months from 2024-09-19.

Traditional vs Special vs Abbreviated 510(k) (last 24 months)

Third-party review vs FDA review (last 24 months)

The 10 product codes with the most clearances (last 24 months)

Methodology

• Source: the openFDA device 510(k) dataset (public domain, CC0), loaded into Caduvo's warehouse.
• Included: decisions FDA records as substantially equivalent (decision codes SESE, SN, SESK, SESU, SEKD, ST, SESD, SESP, PT, SI). De Novo grants (DENG) and not-substantially-equivalent decisions are excluded.
• Review days: decision_date minus date_received, in calendar days. This includes time on hold while FDA waits for the sponsor's answers to an Additional Information request, so it is longer than MDUFA "FDA days".
• Excluded from day statistics: records whose decision date precedes their receipt date (0 in the current data). They still count as clearances.
• Windows: "last 12 months" means decisions after 2025-09-19 up to 2026-09-19, the latest decision date in the data; prior windows step back 12 months at a time. Calendar years use the decision date; 2026 is a partial year.
• Panels: the advisory committee recorded on the 510(k). Third-party: openFDA's third_party_flag; for these the FDA receipt date follows the third party's review, so that time is not counted. Submission type: openFDA's clearance_type.
• Medians over fewer than 5 clearances are not shown. 75th percentile uses linear interpolation.

Download the tables as CSV (per year, per panel, per panel and year, submission type, third-party and top product codes).

Cite this page

Caduvo. "FDA 510(k) Review Times by Panel, 2026." Data from openFDA, as of September 19, 2026. https://caduvo.com/fda/510k-review-times

Frequently asked questions

How long does FDA 510(k) review take in 2026?

The median cleared 510(k) took 130 calendar days from FDA receipt to decision in the 12 months to September 19, 2026 (3,289 clearances); a quarter took longer than 224 days. That includes time on hold for additional information, so it runs longer than FDA's 90-day MDUFA review goal, which counts FDA days only.

Which FDA review panel clears 510(k)s fastest?

Over the last 24 months, among panels with at least 20 clearances: Clinical Toxicology (median 53 days) was fastest and Pathology (238 days) slowest.

Is a Special 510(k) faster than a Traditional 510(k)?

Yes. Over the last 24 months Special 510(k)s took a median 30 days (1,005 clearances) and Traditional 510(k)s 146 days (5,404). Abbreviated 510(k)s took 142 days.

Does third-party 510(k) review save time?

Over the last 24 months, 123 clearances went through an FDA-recognized third-party review organization, with a median of 28 days from FDA receipt to decision, against 128 days for the 6,402 reviewed by FDA alone. The FDA clock starts when FDA receives the third party's recommendation, so the third party's own review time is not counted. Only eligible device types can use third-party review.

How are these 510(k) review times calculated?

Calendar days from the date FDA received the 510(k) to the decision date, for cleared (substantially equivalent) decisions in openFDA. Medians and 75th percentiles; windows end at the latest decision date in the data (September 19, 2026).

Look up a single clearance in the free 510(k) database search, or see review times for one device type on its FDA product code page.

Source: openFDA device 510(k) data (CC0, public domain), data as of September 19, 2026. Data from openFDA; not reviewed or endorsed by FDA. Not regulatory advice.