Guide
Who clears the most 510(k)s?
1,957 companies received FDA’s 3,198 510(k) clearances in 2025; the most active, Olympus Medical Systems Corp., received 32. Over 2021–2025, the ten most active held 4.4% of clearances and the top fifty 13%. 23% of 2025’s clearances went to applicants with no earlier FDA decision under their name.
Figures from FDA decisions to Oct 23, 2026 recomputed weekly, last Nov 3, 2026
Companies cleared, 2025
1,957
3,198 clearances
Top ten’s share
4.4%
of clearances, 2021–2025
Top fifty’s share
13%
of clearances, 2021–2025
First-time applicants
23%
of 2025’s clearances
The most active applicants in 2025
Counted by FDA applicant name. A group that files under several names, such as a company and its divisions, appears once per name; each name has its own company page.
The most active applicants, 2021–2025
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How many applicants are new?
643 companies received their first FDA decision in 2025, accounting for 739 clearances (23%). Most 510(k) applicants file rarely: 6,129 companies shared the 15,763 clearances of 2021–2025.
Companies receiving a 510(k) clearance, per year
1,957in 2025
2026 to Oct 23, 2026, outlined.
The most active applicants by review panel
Doing this for your own device? A 510(k) Report starts from your device concept: it finds the product code and pathway, ranks candidate predicates side by side, and weighs their family trees’ recall history and review times. $995, emailed as a PDF, usually within a few hours.
How these figures are computed
Every 510(k) clearance in FDA’s records, counted by applicant name with case, punctuation and legal form ignored (“Zavation, LLC” and “ZAVATION LLC” are one applicant; “Zavation Medical Products, LLC” is another). A first-time applicant has no FDA decision under its name before the year shown. The figures are recomputed from FDA’s records every week; see the methodology.