How long does a 510(k) take?

Review time by 510(k) type

Calendar days from FDA receipt to clearance, decisions 2018-01-01 to 2026-10-06

Type	n	25th	Median	75th	80th	90th
Traditional	22,438	90	148	246	263	308
Special	4,101	28	30	65	79	132
Abbreviated	437	90	144	243	259	294
All clearances	27,049	74	129	230	253	291

"All clearances" also counts 73 clearances whose type field holds another value. 290 decisions in the window were not clearances (not substantially equivalent, withdrawn and so on) and are left out.

What these numbers measure

The days between the two dates FDA publishes for each 510(k): when it received the submission and when it decided. That is calendar time, and it includes any time the submission spent on hold waiting for the sponsor to answer FDA's questions. FDA's own performance figures count FDA days and stop the clock during a hold, so they run shorter. For planning, calendar time is the number your schedule lives with.

Preparing the submission comes before any of this: design verification, testing and writing the 510(k) itself usually take far longer than the review.

Review time by decision year

Median calendar days by year of decision. The 2026 row covers part of the year and counts only submissions already decided.

Year	n	Median, all	25th–75th	Traditional	Special
2018	3,018	121	70–219	135	30
2019	2,896	118	66–216	139	30
2020	2,897	122	61–220	141	30
2021	2,993	135	81–231	153	30
2022	3,187	143	83–256	162	30
2023	3,299	135	73–245	161	29
2024	3,082	129	70–228	151	29
2025	3,198	126	79–213	142	30
2026 (partial)	2,479	133	83–231	153	30

Third-party review

Clearances flagged as third-party reviewed had a median of 29 days (n = 580) against 131 days for the rest (n = 26,469). Only lower-risk device types are eligible for third-party review, and the review organization's own time may not appear in the dates FDA publishes, so the gap should not be read as the time third-party review saves.

By product code

Review time varies widely by device type. The Clearance Timeline Estimator gives the percentiles for each product code, and every code with at least 10 clearances has its own page in the FDA product code index, for example DQY or DXN.

Source and method

openFDA /device/510k.json, 27,339 records with decision dates from 2018-01-01 to 2026-10-06 (openFDA data as of 2026-09-28), de-duplicated by K number. Percentiles use linear interpolation and are rounded to whole days; a group under 5 clearances shows no figure. The same data and rules drive the Clearance Timeline Estimator.