FDA 510(k) Clearances - March 2022
288 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
March 2022 overview
The FDA cleared 288 medical devices in March 2022 through the 510(k) premarket notification pathway. This compares to 203 clearances in February 2022 - an increase of 85 (+41.9%).
General Hospital led all specialties with 69 cleared devices. The fastest average review was Physical Medicine at 116 days. The slowest was Hematology at 722 days.
Overall average review time: 185 days, ranging from 2 to 722 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - March 2022
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 | 69 | 211 | 21 | 659 | +34 |
| Orthopedic | 42 | 132 | 17 | 673 | +16 |
| Radiology | 40 | 154 | 14 | 447 | +14 |
| General & Plastic Surgery | 31 | 177 | 13 | 407 | +7 |
| Cardiovascular | 24 | 163 | 20 | 324 | +5 |
| Dental | 17 | 242 | 2 | 592 | -2 |
| Physical Medicine | 12 | 116 | 22 | 261 | +6 |
| Neurology | 10 | 172 | 58 | 350 | +2 |
| Gastroenterology & Urology | 10 | 224 | 28 | 604 | - |
| Anesthesiology | 8 | 278 | 90 | 446 | +4 |
| Obstetrics & Gynecology | 7 | 171 | 66 | 357 | -4 |
| Chemistry | 6 | 318 | 106 | 471 | +3 |
| Ophthalmic | 4 | 180 | 120 | 258 | +1 |
| Microbiology | 2 | 216 | 210 | 221 | -2 |
| Ear, Nose, Throat | 2 | 155 | 137 | 172 | -1 |
| Immunology | 2 | 137 | 61 | 212 | +1 |
| Pathology | 1 | 349 | 349 | 349 | +1 |
| Hematology | 1 | 722 | 722 | 722 | +1 |
| Total | 288 | 185 | 2 | 722 | +85 |
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 722 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 2022 with 69 clearances - 24% of all monthly clearances.
Review time spread
Hematology posted the highest average at 722 days. Physical Medicine was fastest at 116 days. The gap of 606 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in March 2022 were Siemens Medical Solutions USA, Inc. (3) , Iray Technology Taicang , Ltd. (3) , Canon Medical Systems Corporation (2) , Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2) and STERIS Corporation (2) . Together, these five manufacturers accounted for 12 of the 288 total clearances - 4% of all March activity.
About this data
This report covers FDA 510(k) submissions with a decision date in March 2022 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.