FDA 510(k) Clearances - January 2023
200 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
January 2023 overview
The FDA cleared 200 medical devices in January 2023 through the 510(k) premarket notification pathway. This compares to 287 clearances in December 2022 - a decrease of 87 (-30.3%).
Orthopedic led all specialties with 44 cleared devices. The fastest average review was Hematology at 30 days. The slowest was Dental at 390 days.
Overall average review time: 196 days, ranging from 12 to 1356 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - January 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 December |
|---|---|---|---|---|---|
| Orthopedic | 44 | 159 | 27 | 642 | -1 |
| Radiology | 28 | 133 | 21 | 381 | -4 |
| General & Plastic Surgery | 25 | 181 | 26 | 638 | -4 |
| General Hospital | 21 | 212 | 30 | 780 | -16 |
| Neurology | 15 | 156 | 18 | 522 | +2 |
| Gastroenterology & Urology | 11 | 229 | 77 | 413 | -2 |
| Cardiovascular | 11 | 174 | 27 | 443 | -23 |
| Dental | 10 | 390 | 64 | 1356 | -16 |
| Obstetrics & Gynecology | 8 | 149 | 23 | 432 | +2 |
| Chemistry | 7 | 342 | 12 | 767 | - |
| Microbiology | 7 | 278 | 120 | 590 | +2 |
| Physical Medicine | 5 | 338 | 123 | 736 | -1 |
| Anesthesiology | 4 | 320 | 30 | 741 | -12 |
| Ear, Nose, Throat | 3 | 129 | 27 | 261 | -1 |
| Hematology | 1 | 30 | 30 | 30 | -3 |
| Total | 200 | 196 | 12 | 1356 | -87 |
Key observations
Fastest reviews
The fastest individual clearance took 12 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 1356 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 January 2023 with 44 clearances - 22% of all monthly clearances.
Review time spread
Dental posted the highest average at 390 days. Hematology was fastest at 30 days. The gap of 360 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in January 2023 were Medacta International S.A. (3) , Beckman Coulter, Inc. (2) , Lg Electronics.Inc (2) , Dentis Co., Ltd. (2) and Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2) . Together, these five manufacturers accounted for 11 of the 200 total clearances - 6% of all January activity.
About this data
This report covers FDA 510(k) submissions with a decision date in January 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.