FDA 510(k) Clearances - January 2025
254 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
January 2025 overview
The FDA cleared 254 medical devices in January 2025 through the 510(k) premarket notification pathway. This compares to 294 clearances in December 2024 - a decrease of 40 (-13.6%).
Radiology led all specialties with 38 cleared devices. The fastest average review was Ophthalmic at 25 days. The slowest was Pathology at 258 days.
Overall average review time: 150 days, ranging from 1 to 634 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - January 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 December |
|---|---|---|---|---|---|
| Radiology | 38 | 162 | 57 | 269 | -2 |
| Orthopedic | 33 | 90 | 21 | 270 | -16 |
| General & Plastic Surgery | 29 | 136 | 25 | 464 | -9 |
| Cardiovascular | 21 | 168 | 30 | 271 | - |
| Neurology | 18 | 131 | 16 | 254 | -2 |
| Dental | 17 | 216 | 1 | 634 | -10 |
| Gastroenterology & Urology | 17 | 152 | 28 | 266 | -1 |
| Physical Medicine | 15 | 181 | 34 | 419 | +3 |
| Microbiology | 15 | 152 | 28 | 357 | +7 |
| General Hospital | 14 | 84 | 27 | 213 | -3 |
| Anesthesiology | 9 | 185 | 29 | 451 | -8 |
| Chemistry | 8 | 196 | 57 | 273 | +4 |
| Obstetrics & Gynecology | 7 | 197 | 60 | 273 | +1 |
| Ear, Nose, Throat | 7 | 186 | 108 | 268 | +3 |
| Pathology | 2 | 258 | 248 | 267 | -2 |
| Hematology | 2 | 60 | 30 | 90 | +2 |
| Immunology | 1 | 230 | 230 | 230 | - |
| Ophthalmic | 1 | 25 | 25 | 25 | -5 |
| Total | 254 | 150 | 1 | 634 | -40 |
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 634 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 January 2025 with 38 clearances - 15% of all monthly clearances.
Review time spread
Pathology posted the highest average at 258 days. Ophthalmic was fastest at 25 days. The gap of 233 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in January 2025 were Arthrex, Inc. (4) , Olympus Medical Systems Corporation (2) , Shanghai United Imaging Healthcare Co., Ltd. (2) , Roche Molecular Systems, Inc. (2) and Cepheid (2) . Together, these five manufacturers accounted for 12 of the 254 total clearances - 5% of all January activity.
About this data
This report covers FDA 510(k) submissions with a decision date in January 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.