How long does a 510(k) take?

These are calendar days from the date FDA received the 510(k) to the date it decided, as FDA’s own records give them. They include any time the file sat on hold while FDA waited for the applicant’s answers to its questions, so they run longer than FDA’s 90-day review goal, whose clock stops during those holds.

They are the days a company actually waits. Planning to the median, 126 days in 2025, means a coin-flip chance of waiting longer; planning to 213 days covers three 510(k)s in four.

The median was 125 days in 2015 and 126 days in 2025. FDA cleared 3,198 510(k)s in 2025.

The type of 510(k) matters most. A Special 510(k), for a change to the company’s own cleared device, had a median of 29 days in 2021–2025, against 153 for a Traditional 510(k). A 510(k) reviewed first by an FDA-accredited third party had a median of 29 days, against 135 without one, though only 323 of 15,763 510(k)s used one; the program covers a limited list of device types.

FDA assigns each 510(k) to a review panel by medical specialty. In 2021–2025 the orthopedic panel was fastest, with a median of 90 days, and the immunology panel slowest, at 264.

Of the 173 product codes with at least 20 510(k)s decided 2021–2025, these had the shortest and longest medians. Every product code page shows its own review times by year.

Every 510(k) clearance in FDA’s 510(k) database with a receipt date, 15,763 of them decided 2021–2025. Days run from FDA’s “date received” to its “decision date”; a handful with impossible dates are left out. Panels with fewer than 50 510(k)s in the five years are not ranked. The figures are recomputed from FDA’s records every week; see the methodology.