FDA 510(k) Clearances - March 2021
272 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
March 2021 overview
The FDA cleared 272 medical devices in March 2021 through the 510(k) premarket notification pathway. This compares to 228 clearances in February 2021 - an increase of 44 (+19.3%).
General Hospital led all specialties with 68 cleared devices. The fastest average review was Orthopedic at 81 days. The slowest was Physical Medicine at 265 days.
Overall average review time: 155 days, ranging from 4 to 645 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - March 2021
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 |
|---|---|---|---|---|---|
| General Hospital | 68 | 190 | 25 | 329 | +28 |
| Orthopedic | 43 | 81 | 20 | 280 | -1 |
| Radiology | 37 | 109 | 27 | 230 | - |
| Cardiovascular | 23 | 140 | 28 | 435 | +4 |
| Dental | 20 | 170 | 4 | 535 | -4 |
| General & Plastic Surgery | 19 | 132 | 17 | 397 | -4 |
| Neurology | 18 | 170 | 23 | 426 | +4 |
| Physical Medicine | 11 | 265 | 155 | 645 | +4 |
| Anesthesiology | 10 | 192 | 59 | 290 | +6 |
| Gastroenterology & Urology | 8 | 258 | 156 | 539 | +4 |
| Microbiology | 6 | 149 | 102 | 257 | +2 |
| Ophthalmic | 3 | 189 | 155 | 246 | +2 |
| Ear, Nose, Throat | 3 | 143 | 65 | 274 | - |
| Obstetrics & Gynecology | 2 | 246 | 221 | 270 | -2 |
| Toxicology | 1 | 209 | 209 | 209 | +1 |
| Total | 272 | 155 | 4 | 645 | +44 |
Key observations
Fastest reviews
The fastest individual clearance took 4 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 645 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 Hospital
General Hospital led March 2021 with 68 clearances - 25% of all monthly clearances.
Review time spread
Physical Medicine posted the highest average at 265 days. Orthopedic was fastest at 81 days. The gap of 184 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in March 2021 were Shen Wei (Usa), Inc. (7) , Medacta International S.A. (4) , Siemens Medical Solutions USA, Inc. (4) , Canon Medical Systems Corporation (3) and Orthofix, Inc. (3) . Together, these five manufacturers accounted for 21 of the 272 total clearances - 8% of all March activity.
About this data
This report covers FDA 510(k) submissions with a decision date in March 2021 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.