FDA 510(k) Clearances - March 2023
317 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
March 2023 overview
The FDA cleared 317 medical devices in March 2023 through the 510(k) premarket notification pathway. This compares to 251 clearances in February 2023 - an increase of 66 (+26.3%).
Orthopedic led all specialties with 59 cleared devices. The fastest average review was Hematology at 31 days. The slowest was Anesthesiology at 324 days.
Overall average review time: 193 days, ranging from 2 to 1127 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - March 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 February |
|---|---|---|---|---|---|
| Orthopedic | 59 | 172 | 20 | 1127 | +21 |
| General & Plastic Surgery | 45 | 180 | 26 | 624 | +3 |
| Radiology | 42 | 197 | 21 | 721 | +2 |
| General Hospital | 34 | 194 | 21 | 616 | +4 |
| Cardiovascular | 26 | 168 | 23 | 547 | +3 |
| Neurology | 19 | 219 | 23 | 421 | +5 |
| Dental | 17 | 196 | 2 | 598 | +3 |
| Microbiology | 15 | 205 | 29 | 526 | +9 |
| Gastroenterology & Urology | 13 | 216 | 30 | 602 | -2 |
| Anesthesiology | 10 | 324 | 90 | 602 | +3 |
| Physical Medicine | 9 | 152 | 59 | 233 | +4 |
| Obstetrics & Gynecology | 8 | 233 | 27 | 448 | +4 |
| Ophthalmic | 5 | 254 | 128 | 370 | +3 |
| Chemistry | 5 | 197 | 69 | 257 | +1 |
| Ear, Nose, Throat | 4 | 149 | 63 | 222 | +2 |
| Toxicology | 3 | 220 | 60 | 440 | +2 |
| Immunology | 2 | 212 | 90 | 333 | +1 |
| Hematology | 1 | 31 | 31 | 31 | - |
| Total | 317 | 193 | 2 | 1127 | +66 |
Key observations
Fastest reviews
The fastest individual clearance took 2 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 1127 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 March 2023 with 59 clearances - 19% of all monthly clearances.
Review time spread
Anesthesiology posted the highest average at 324 days. Hematology was fastest at 31 days. The gap of 293 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in March 2023 were Becton, Dickinson and Company (5) , Baxter Healthcare Corporation (3) , Inari Medical, Inc. (3) , Canon Medical Systems Corporation (3) and Arthrex, Inc. (3) . Together, these five manufacturers accounted for 17 of the 317 total clearances - 5% of all March activity.
About this data
This report covers FDA 510(k) submissions with a decision date in March 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.