FDA 510(k) Clearances - February 2022
203 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
February 2022 overview
The FDA cleared 203 medical devices in February 2022 through the 510(k) premarket notification pathway. This compares to 235 clearances in January 2022 - a decrease of 32 (-13.6%).
General Hospital led all specialties with 35 cleared devices. The fastest average review was Immunology at 29 days. The slowest was Toxicology at 525 days.
Overall average review time: 179 days, ranging from 1 to 810 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - February 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 January |
|---|---|---|---|---|---|
| General Hospital | 35 | 156 | 24 | 517 | -19 |
| Orthopedic | 26 | 175 | 28 | 623 | -16 |
| Radiology | 26 | 124 | 17 | 291 | -1 |
| General & Plastic Surgery | 24 | 147 | 14 | 491 | +4 |
| Cardiovascular | 19 | 195 | 30 | 476 | -2 |
| Dental | 19 | 178 | 1 | 644 | -1 |
| Obstetrics & Gynecology | 11 | 208 | 28 | 449 | +8 |
| Gastroenterology & Urology | 10 | 167 | 29 | 300 | -1 |
| Neurology | 8 | 235 | 29 | 552 | - |
| Physical Medicine | 6 | 235 | 30 | 510 | -2 |
| Microbiology | 4 | 281 | 148 | 615 | +3 |
| Anesthesiology | 4 | 262 | 50 | 498 | -1 |
| Ophthalmic | 3 | 233 | 25 | 421 | -2 |
| Chemistry | 3 | 492 | 197 | 810 | -2 |
| Ear, Nose, Throat | 3 | 139 | 103 | 159 | - |
| Toxicology | 1 | 525 | 525 | 525 | - |
| Immunology | 1 | 29 | 29 | 29 | +1 |
| Total | 203 | 179 | 1 | 810 | -32 |
Key observations
Fastest reviews
The fastest individual clearance took 1 day. Reviews under 5 days typically reflect Special 510(k) submissions for minor modifications to already-cleared devices.
Longest review
The longest individual review reached 810 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 February 2022 with 35 clearances - 17% of all monthly clearances.
Review time spread
Toxicology posted the highest average at 525 days. Immunology was fastest at 29 days. The gap of 496 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in February 2022 were Vy Spine, LLC (2) , Siemens Medical Solutions USA, Inc. (2) , Stryker GmbH (1) , Prismatik Dentalcraft, Inc. (1) and Ultradent Products, Inc. (1) . Together, these five manufacturers accounted for 7 of the 203 total clearances - 3% of all February activity.
About this data
This report covers FDA 510(k) submissions with a decision date in February 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.