FDA 510(k) Clearances - February 2023
251 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
February 2023 overview
The FDA cleared 251 medical devices in February 2023 through the 510(k) premarket notification pathway. This compares to 200 clearances in January 2023 - an increase of 51 (+25.5%).
General & Plastic Surgery led all specialties with 42 cleared devices. The fastest average review was Chemistry at 83 days. The slowest was Pathology at 590 days.
Overall average review time: 185 days, ranging from 6 to 832 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - February 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 January |
|---|---|---|---|---|---|
| General & Plastic Surgery | 42 | 190 | 9 | 692 | +17 |
| Radiology | 40 | 143 | 19 | 555 | +12 |
| Orthopedic | 38 | 163 | 28 | 530 | -6 |
| General Hospital | 30 | 228 | 52 | 832 | +9 |
| Cardiovascular | 23 | 169 | 28 | 440 | +12 |
| Gastroenterology & Urology | 15 | 154 | 17 | 269 | +4 |
| Neurology | 14 | 186 | 28 | 582 | -1 |
| Dental | 14 | 194 | 6 | 646 | +4 |
| Anesthesiology | 7 | 245 | 129 | 493 | +3 |
| Microbiology | 6 | 193 | 77 | 413 | -1 |
| Physical Medicine | 5 | 179 | 66 | 344 | - |
| Obstetrics & Gynecology | 4 | 304 | 195 | 418 | -4 |
| Chemistry | 4 | 83 | 53 | 132 | -3 |
| Ophthalmic | 2 | 160 | 27 | 292 | +2 |
| Pathology | 2 | 590 | 501 | 678 | +2 |
| Ear, Nose, Throat | 2 | 333 | 285 | 380 | -1 |
| Toxicology | 1 | 132 | 132 | 132 | +1 |
| Immunology | 1 | 421 | 421 | 421 | +1 |
| Hematology | 1 | 139 | 139 | 139 | - |
| Total | 251 | 185 | 6 | 832 | +51 |
Key observations
Fastest reviews
The fastest individual clearance took 6 days. Reviews under 5 days typically reflect Special 510(k) submissions for minor modifications to already-cleared devices.
Longest review
The longest individual review reached 832 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: General & Plastic Surgery
General & Plastic Surgery led February 2023 with 42 clearances - 17% of all monthly clearances.
Review time spread
Pathology posted the highest average at 590 days. Chemistry was fastest at 83 days. The gap of 507 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in February 2023 were bioMerieux, Inc. (3) , Siemens Medical Solutions USA, Inc. (3) , Elekta Solutions AB (3) , Biosense Webster, Inc. (2) and Stryker Corporation (2) . Together, these five manufacturers accounted for 13 of the 251 total clearances - 5% of all February activity.
About this data
This report covers FDA 510(k) submissions with a decision date in February 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.