FDA 510(k) Clearances - April 2026
312 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
April 2026 overview
The FDA cleared 312 medical devices in April 2026 through the 510(k) premarket notification pathway. This compares to 283 clearances in March 2026 - an increase of 29 (+10.2%).
Orthopedic led all specialties with 46 cleared devices. The fastest average review was Toxicology at 109 days. The slowest was Hematology at 309 days.
Overall average review time: 155 days, ranging from 1 to 635 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - April 2026
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 |
|---|---|---|---|---|---|
| Orthopedic | 46 | 123 | 22 | 604 | -9 |
| Cardiovascular | 44 | 146 | 18 | 452 | +23 |
| Radiology | 39 | 167 | 31 | 274 | -13 |
| General & Plastic Surgery | 26 | 139 | 27 | 635 | -7 |
| Gastroenterology & Urology | 23 | 168 | 21 | 420 | +7 |
| Dental | 22 | 127 | 1 | 266 | -1 |
| General Hospital | 20 | 220 | 22 | 452 | +11 |
| Neurology | 16 | 139 | 26 | 267 | -4 |
| Obstetrics & Gynecology | 13 | 154 | 86 | 437 | +5 |
| Microbiology | 12 | 116 | 45 | 270 | +4 |
| Physical Medicine | 12 | 149 | 86 | 246 | - |
| Anesthesiology | 11 | 228 | 25 | 338 | +3 |
| Chemistry | 10 | 178 | 73 | 270 | +7 |
| Ear, Nose, Throat | 7 | 126 | 29 | 269 | +1 |
| Ophthalmic | 5 | 204 | 135 | 269 | -1 |
| Hematology | 4 | 309 | 158 | 405 | +3 |
| Toxicology | 1 | 109 | 109 | 109 | -1 |
| Immunology | 1 | 270 | 270 | 270 | +1 |
| Total | 312 | 155 | 1 | 635 | +29 |
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 635 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 April 2026 with 46 clearances - 15% of all monthly clearances.
Review time spread
Hematology posted the highest average at 309 days. Toxicology was fastest at 109 days. The gap of 200 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in April 2026 were Roche Diagnostics (5) , Becton, Dickinson and Company (4) , Siemens Medical Solutions USA, Inc. (3) , Abbott Medical (3) and Med-El Elektromedizinische Ger?te GmbH (3) . Together, these five manufacturers accounted for 18 of the 312 total clearances - 6% of all April activity.
About this data
This report covers FDA 510(k) submissions with a decision date in April 2026 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.