FDA 510(k) Clearances - April 2022
257 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
April 2022 overview
The FDA cleared 257 medical devices in April 2022 through the 510(k) premarket notification pathway. This compares to 288 clearances in March 2022 - a decrease of 31 (-10.8%).
Radiology led all specialties with 44 cleared devices. The fastest average review was Ear, Nose, Throat at 94 days. The slowest was Hematology at 915 days.
Overall average review time: 176 days, ranging from 14 to 915 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - April 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 March |
|---|---|---|---|---|---|
| Radiology | 44 | 123 | 14 | 464 | +4 |
| General Hospital | 44 | 172 | 45 | 727 | -25 |
| General & Plastic Surgery | 33 | 171 | 24 | 616 | +2 |
| Orthopedic | 33 | 149 | 18 | 447 | -9 |
| Cardiovascular | 31 | 135 | 17 | 276 | +7 |
| Gastroenterology & Urology | 16 | 242 | 52 | 452 | +6 |
| Neurology | 14 | 197 | 34 | 468 | +4 |
| Dental | 12 | 205 | 50 | 590 | -5 |
| Obstetrics & Gynecology | 6 | 208 | 123 | 275 | -1 |
| Anesthesiology | 6 | 252 | 30 | 595 | -2 |
| Ophthalmic | 4 | 245 | 168 | 329 | - |
| Microbiology | 3 | 299 | 113 | 576 | +1 |
| Physical Medicine | 3 | 256 | 30 | 448 | -9 |
| Chemistry | 3 | 365 | 120 | 582 | -3 |
| Ear, Nose, Throat | 2 | 94 | 90 | 97 | - |
| Immunology | 1 | 654 | 654 | 654 | -1 |
| Hematology | 1 | 915 | 915 | 915 | - |
| Toxicology | 1 | 214 | 214 | 214 | +1 |
| Total | 257 | 176 | 14 | 915 | -31 |
Key observations
Fastest reviews
The fastest individual clearance took 14 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 915 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: Radiology
Radiology led April 2022 with 44 clearances - 17% of all monthly clearances.
Review time spread
Hematology posted the highest average at 915 days. Ear, Nose, Throat was fastest at 94 days. The gap of 821 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in April 2022 were GE Healthcare Finland Oy (3) , Brainlab AG (3) , Canon Medical Systems Corporation (2) , Covidien (2) and Siemens Medical Solutions USA, Inc. (2) . Together, these five manufacturers accounted for 12 of the 257 total clearances - 5% of all April activity.
About this data
This report covers FDA 510(k) submissions with a decision date in April 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.