FDA 510(k) Clearances - December 2025
289 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
December 2025 overview
The FDA cleared 289 medical devices in December 2025 through the 510(k) premarket notification pathway. This compares to 204 clearances in November 2025 - an increase of 85 (+41.7%).
Orthopedic led all specialties with 42 cleared devices. The fastest average review was Toxicology at 36 days. The slowest was Pathology at 397 days.
Overall average review time: 156 days, ranging from 1 to 865 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - December 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 November |
|---|---|---|---|---|---|
| Orthopedic | 42 | 119 | 17 | 273 | +13 |
| General & Plastic Surgery | 41 | 117 | 10 | 314 | +9 |
| Radiology | 40 | 166 | 28 | 271 | +6 |
| Cardiovascular | 31 | 172 | 21 | 401 | +15 |
| Dental | 23 | 137 | 1 | 450 | +5 |
| General Hospital | 20 | 203 | 27 | 423 | +8 |
| Anesthesiology | 18 | 220 | 65 | 865 | +12 |
| Gastroenterology & Urology | 16 | 168 | 32 | 264 | +9 |
| Neurology | 14 | 141 | 29 | 268 | -6 |
| Physical Medicine | 10 | 141 | 90 | 252 | +1 |
| Obstetrics & Gynecology | 9 | 134 | 23 | 296 | +6 |
| Chemistry | 7 | 178 | 23 | 264 | +3 |
| Microbiology | 6 | 234 | 16 | 496 | -4 |
| Ophthalmic | 4 | 158 | 125 | 207 | +2 |
| Immunology | 4 | 186 | 80 | 264 | +4 |
| Ear, Nose, Throat | 2 | 224 | 182 | 266 | +2 |
| Toxicology | 1 | 36 | 36 | 36 | - |
| Pathology | 1 | 397 | 397 | 397 | - |
| Total | 289 | 156 | 1 | 865 | +85 |
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 865 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 December 2025 with 42 clearances - 15% of all monthly clearances.
Review time spread
Pathology posted the highest average at 397 days. Toxicology was fastest at 36 days. The gap of 361 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in December 2025 were Covidien, LLC (3) , Intuitive Surgical, Inc. (3) , Arthrex, Inc. (2) , Unimed Medical Supplies, Inc. (2) and Abbott Medical (2) . Together, these five manufacturers accounted for 12 of the 289 total clearances - 4% of all December activity.
About this data
This report covers FDA 510(k) submissions with a decision date in December 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.