FDA 510(k) Clearances - December 2023
308 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
December 2023 overview
The FDA cleared 308 medical devices in December 2023 through the 510(k) premarket notification pathway. This compares to 250 clearances in November 2023 - an increase of 58 (+23.2%).
Radiology led all specialties with 49 cleared devices. The fastest average review was Immunology at 28 days. The slowest was Anesthesiology at 272 days.
Overall average review time: 156 days, ranging from 1 to 649 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - December 2023
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 |
|---|---|---|---|---|---|
| Radiology | 49 | 149 | 24 | 358 | +13 |
| Orthopedic | 46 | 137 | 16 | 373 | +8 |
| General & Plastic Surgery | 33 | 145 | 14 | 649 | -3 |
| Cardiovascular | 32 | 128 | 18 | 420 | +6 |
| General Hospital | 25 | 145 | 24 | 553 | +5 |
| Dental | 25 | 193 | 1 | 529 | +6 |
| Neurology | 19 | 173 | 30 | 602 | +2 |
| Gastroenterology & Urology | 17 | 156 | 28 | 453 | -2 |
| Chemistry | 11 | 239 | 88 | 452 | +7 |
| Microbiology | 9 | 174 | 26 | 353 | +3 |
| Obstetrics & Gynecology | 9 | 118 | 16 | 192 | +5 |
| Anesthesiology | 8 | 272 | 111 | 459 | +3 |
| Ophthalmic | 7 | 196 | 24 | 384 | +1 |
| Physical Medicine | 6 | 157 | 43 | 373 | +2 |
| Toxicology | 4 | 114 | 82 | 166 | +2 |
| Ear, Nose, Throat | 3 | 151 | 87 | 271 | -1 |
| Hematology | 3 | 185 | 31 | 265 | +1 |
| Pathology | 1 | 88 | 88 | 88 | +1 |
| Immunology | 1 | 28 | 28 | 28 | -1 |
| Total | 308 | 156 | 1 | 649 | +58 |
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 649 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 December 2023 with 49 clearances - 16% of all monthly clearances.
Review time spread
Anesthesiology posted the highest average at 272 days. Immunology was fastest at 28 days. The gap of 244 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in December 2023 were Siemens Medical Solutions USA, Inc. (6) , Tyber Medical, LLC (4) , Medtronic, Inc. (3) , Depuy Ireland UC (3) and Boston Scientific Corporation (2) . Together, these five manufacturers accounted for 18 of the 308 total clearances - 6% of all December activity.
About this data
This report covers FDA 510(k) submissions with a decision date in December 2023 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.