FDA 510(k) Clearances - February 2025
234 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
February 2025 overview
The FDA cleared 234 medical devices in February 2025 through the 510(k) premarket notification pathway. This compares to 254 clearances in January 2025 - a decrease of 20 (-7.9%).
Radiology led all specialties with 36 cleared devices. The fastest average review was Toxicology at 80 days. The slowest was Pathology at 259 days.
Overall average review time: 147 days, ranging from 1 to 438 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - February 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 January |
|---|---|---|---|---|---|
| Radiology | 36 | 140 | 18 | 301 | -2 |
| Orthopedic | 36 | 135 | 20 | 308 | +3 |
| General & Plastic Surgery | 29 | 129 | 19 | 429 | - |
| Cardiovascular | 20 | 187 | 33 | 272 | -1 |
| Dental | 18 | 148 | 1 | 318 | +1 |
| General Hospital | 16 | 122 | 27 | 269 | +2 |
| Neurology | 12 | 152 | 55 | 271 | -6 |
| Microbiology | 11 | 136 | 23 | 319 | -4 |
| Gastroenterology & Urology | 10 | 144 | 27 | 257 | -7 |
| Anesthesiology | 10 | 207 | 111 | 438 | +1 |
| Obstetrics & Gynecology | 9 | 206 | 88 | 269 | +2 |
| Physical Medicine | 9 | 142 | 46 | 289 | -6 |
| Chemistry | 4 | 101 | 28 | 261 | -4 |
| Toxicology | 4 | 80 | 41 | 175 | +4 |
| Hematology | 4 | 155 | 28 | 360 | +2 |
| Ear, Nose, Throat | 3 | 171 | 127 | 203 | -4 |
| Ophthalmic | 2 | 114 | 94 | 133 | +1 |
| Pathology | 1 | 259 | 259 | 259 | -1 |
| Total | 234 | 147 | 1 | 438 | -20 |
Key observations
Fastest reviews
The fastest individual clearance took 1 day. Reviews under 5 days typically reflect Special 510(k) submissions for minor modifications to already-cleared devices.
Longest review
The longest individual review reached 438 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: Radiology
Radiology led February 2025 with 36 clearances - 15% of all monthly clearances.
Review time spread
Pathology posted the highest average at 259 days. Toxicology was fastest at 80 days. The gap of 179 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in February 2025 were Thermo Fisher Scientific (3) , Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2) , Cepheid (2) , Philips Ultrasound, LLC (2) and Institut Straumann AG (2) . Together, these five manufacturers accounted for 11 of the 234 total clearances - 5% of all February activity.
About this data
This report covers FDA 510(k) submissions with a decision date in February 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.