FDA 510(k) Clearances - December 2024
294 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
December 2024 overview
The FDA cleared 294 medical devices in December 2024 through the 510(k) premarket notification pathway. This compares to 258 clearances in November 2024 - an increase of 36 (+14.0%).
Orthopedic led all specialties with 49 cleared devices. The fastest average review was Toxicology at 39 days. The slowest was Immunology at 809 days.
Overall average review time: 146 days, ranging from 1 to 809 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - December 2024
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 | 49 | 100 | 14 | 294 | -5 |
| Radiology | 40 | 137 | 20 | 280 | +2 |
| General & Plastic Surgery | 38 | 148 | 20 | 592 | - |
| Dental | 27 | 148 | 1 | 455 | +7 |
| Cardiovascular | 21 | 160 | 27 | 576 | -3 |
| Neurology | 20 | 152 | 29 | 269 | +7 |
| Gastroenterology & Urology | 18 | 117 | 23 | 270 | +6 |
| Anesthesiology | 17 | 249 | 60 | 791 | +7 |
| General Hospital | 17 | 133 | 26 | 307 | +5 |
| Physical Medicine | 12 | 155 | 30 | 463 | -3 |
| Microbiology | 8 | 79 | 14 | 196 | +2 |
| Ophthalmic | 6 | 183 | 20 | 459 | +4 |
| Obstetrics & Gynecology | 6 | 169 | 25 | 240 | +2 |
| Ear, Nose, Throat | 4 | 248 | 85 | 448 | +3 |
| Chemistry | 4 | 197 | 89 | 246 | -2 |
| Pathology | 4 | 197 | 81 | 458 | +4 |
| Toxicology | 2 | 39 | 29 | 49 | - |
| Immunology | 1 | 809 | 809 | 809 | +1 |
| Total | 294 | 146 | 1 | 809 | +36 |
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 809 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 2024 with 49 clearances - 17% of all monthly clearances.
Review time spread
Immunology posted the highest average at 809 days. Toxicology was fastest at 39 days. The gap of 770 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in December 2024 were SurGenTec, LLC (3) , Genadyne Biotechnologies, Inc. (2) , Thermo Fisher Scientific (2) , Globus Medical, Inc. (2) and Institut Straumann AG (2) . Together, these five manufacturers accounted for 11 of the 294 total clearances - 4% of all December activity.
About this data
This report covers FDA 510(k) submissions with a decision date in December 2024 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.