FDA 510(k) Clearances - April 2025
282 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
April 2025 overview
The FDA cleared 282 medical devices in April 2025 through the 510(k) premarket notification pathway. This compares to 244 clearances in March 2025 - an increase of 38 (+15.6%).
Orthopedic led all specialties with 39 cleared devices. The fastest average review was Toxicology at 27 days. The slowest was Immunology at 254 days.
Overall average review time: 141 days, ranging from 4 to 573 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - April 2025
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 | 39 | 107 | 14 | 325 | -10 |
| Radiology | 38 | 164 | 27 | 420 | +1 |
| General & Plastic Surgery | 37 | 135 | 15 | 303 | +3 |
| Neurology | 26 | 147 | 28 | 573 | +5 |
| General Hospital | 23 | 145 | 26 | 438 | +9 |
| Cardiovascular | 21 | 145 | 25 | 393 | -2 |
| Dental | 19 | 111 | 4 | 260 | +10 |
| Gastroenterology & Urology | 18 | 114 | 28 | 274 | - |
| Obstetrics & Gynecology | 13 | 145 | 23 | 267 | +7 |
| Microbiology | 9 | 198 | 90 | 354 | - |
| Ophthalmic | 9 | 190 | 55 | 394 | +7 |
| Anesthesiology | 9 | 178 | 107 | 269 | +3 |
| Ear, Nose, Throat | 6 | 175 | 47 | 269 | +3 |
| Physical Medicine | 6 | 132 | 30 | 263 | -1 |
| Chemistry | 4 | 150 | 5 | 249 | +2 |
| Immunology | 2 | 254 | 240 | 268 | +2 |
| Toxicology | 2 | 27 | 24 | 29 | +1 |
| Hematology | 1 | 28 | 28 | 28 | - |
| Total | 282 | 141 | 4 | 573 | +38 |
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 573 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 2025 with 39 clearances - 14% of all monthly clearances.
Review time spread
Immunology posted the highest average at 254 days. Toxicology was fastest at 27 days. The gap of 227 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in April 2025 were Roche Molecular Systems, Inc. (3) , Shenzhen TPH Technology Co., Ltd. (3) , Icu Medical, Inc. (3) , Intuitive Surgical, Inc. (2) and Asahi Intecc Co., Ltd. (2) . Together, these five manufacturers accounted for 13 of the 282 total clearances - 5% of all April activity.
About this data
This report covers FDA 510(k) submissions with a decision date in April 2025 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.