FDA 510(k) Clearance Reports
Monthly analysis of FDA 510(k) medical device clearances. Clearance counts, review times, and top specialties - updated the 5th of each month.
16,492
Clearances (2021–)
6
Years covered
About these reports
Each monthly report covers all FDA 510(k) clearances issued in that calendar month. Data is sourced from the FDA 510(k) public files, published on the 5th of each month and in the public domain (17 U.S.C. § 105).
Reports include clearance counts by specialty, average review times, month-over-month comparisons, and the most active manufacturers. Only cleared decisions are counted (SESE, SESK, SESU, SEKD, SESP, SESD, ST, SN).
Annual summary
| Year | Total cleared | Avg days | Panels active | |
|---|---|---|---|---|
| 2026 | 734 | 147 | 18 | View 2026 → |
| 2025 | 3,195 | 146 | 19 | View 2025 → |
| 2024 | 3,082 | 159 | 19 | View 2024 → |
| 2023 | 3,300 | 176 | 20 | View 2023 → |
| 2022 | 3,190 | 185 | 20 | View 2022 → |
| 2021 | 2,991 | 169 | 19 | View 2021 → |