FDA 510(k) Clearances - March 2025
244 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
March 2025 overview
The FDA cleared 244 medical devices in March 2025 through the 510(k) premarket notification pathway. This compares to 234 clearances in February 2025 - an increase of 10 (+4.3%).
Orthopedic led all specialties with 49 cleared devices. The fastest average review was Orthopedic at 107 days. The slowest was Toxicology at 411 days.
Overall average review time: 143 days, ranging from 3 to 574 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - March 2025
Detailed data
Review time in calendar days from FDA receipt to decision. Source: FDA 510(k) downloadable files.
| Specialty | Cleared | Avg days | Min | Max | vs February |
|---|---|---|---|---|---|
| Orthopedic | 49 | 107 | 12 | 271 | +13 |
| Radiology | 37 | 161 | 33 | 462 | +1 |
| General & Plastic Surgery | 34 | 140 | 27 | 271 | +5 |
| Cardiovascular | 23 | 121 | 20 | 347 | +3 |
| Neurology | 21 | 137 | 29 | 427 | +9 |
| Gastroenterology & Urology | 18 | 165 | 24 | 280 | +8 |
| General Hospital | 14 | 130 | 27 | 366 | -2 |
| Microbiology | 9 | 154 | 28 | 451 | -2 |
| Dental | 9 | 204 | 3 | 574 | -9 |
| Physical Medicine | 7 | 165 | 68 | 315 | -2 |
| Anesthesiology | 6 | 214 | 61 | 469 | -4 |
| Obstetrics & Gynecology | 6 | 145 | 24 | 269 | -3 |
| Ear, Nose, Throat | 3 | 142 | 54 | 247 | - |
| Pathology | 2 | 153 | 79 | 226 | +1 |
| Chemistry | 2 | 144 | 65 | 223 | -2 |
| Ophthalmic | 2 | 195 | 125 | 265 | - |
| Hematology | 1 | 184 | 184 | 184 | -3 |
| Toxicology | 1 | 411 | 411 | 411 | -3 |
| Total | 244 | 143 | 3 | 574 | +10 |
Key observations
Fastest reviews
The fastest individual clearance took 3 days. Reviews under 5 days typically reflect Special 510(k) submissions for minor modifications to already-cleared devices.
Longest review
The longest individual review reached 574 days. Extended reviews typically indicate additional information requests or complex predicate device questions. The FDA's standard target is 90 days from receipt.
Leading specialty: Orthopedic
Orthopedic led March 2025 with 49 clearances - 20% of all monthly clearances.
Review time spread
Toxicology posted the highest average at 411 days. Orthopedic was fastest at 107 days. The gap of 304 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in March 2025 were Arthrex, Inc. (4) , Stryker Instruments (3) , DRTECH Corporation (2) , Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. (2) and Siemens Healthcare GmbH (2) . Together, these five manufacturers accounted for 13 of the 244 total clearances - 5% of all March activity.
About this data
This report covers FDA 510(k) submissions with a decision date in March 2025 and a valid days-to-decision value. 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). Only cleared decisions are counted (SESE, SESK, SESU, SEKD, SESP, SESD, ST, SN).
Maintained by Space Bits, S.L. Not affiliated with or endorsed by the FDA. Verify at accessdata.fda.gov.