FDA 510(k) Clearances - May 2025
299 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
May 2025 overview
The FDA cleared 299 medical devices in May 2025 through the 510(k) premarket notification pathway. This compares to 282 clearances in April 2025 - an increase of 17 (+6.0%).
Radiology led all specialties with 48 cleared devices. The fastest average review was Ophthalmic at 49 days. The slowest was Hematology at 246 days.
Overall average review time: 151 days, ranging from 1 to 587 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - May 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 April |
|---|---|---|---|---|---|
| Radiology | 48 | 172 | 24 | 443 | +10 |
| Orthopedic | 40 | 134 | 26 | 269 | +1 |
| General & Plastic Surgery | 32 | 107 | 7 | 413 | -5 |
| Dental | 32 | 152 | 1 | 587 | +13 |
| Cardiovascular | 29 | 110 | 28 | 385 | +8 |
| Gastroenterology & Urology | 24 | 185 | 28 | 445 | +6 |
| General Hospital | 20 | 167 | 29 | 270 | -3 |
| Neurology | 18 | 144 | 29 | 270 | -8 |
| Anesthesiology | 11 | 177 | 27 | 273 | +2 |
| Physical Medicine | 10 | 166 | 57 | 248 | +4 |
| Microbiology | 9 | 167 | 30 | 386 | - |
| Obstetrics & Gynecology | 8 | 168 | 58 | 269 | -5 |
| Ear, Nose, Throat | 5 | 171 | 125 | 254 | -1 |
| Chemistry | 4 | 174 | 68 | 259 | - |
| Immunology | 3 | 162 | 87 | 249 | +1 |
| Hematology | 3 | 246 | 214 | 270 | +2 |
| Pathology | 2 | 180 | 90 | 269 | +2 |
| Ophthalmic | 1 | 49 | 49 | 49 | -8 |
| Total | 299 | 151 | 1 | 587 | +17 |
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 587 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 May 2025 with 48 clearances - 16% of all monthly clearances.
Review time spread
Hematology posted the highest average at 246 days. Ophthalmic was fastest at 49 days. The gap of 197 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in May 2025 were Shanghai United Imaging Healthcare Co., Ltd. (4) , Arthrex, Inc. (4) , Abbott Medical (3) , Signature Orthopaedics Pty, Ltd. (3) and Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (3) . Together, these five manufacturers accounted for 17 of the 299 total clearances - 6% of all May activity.
About this data
This report covers FDA 510(k) submissions with a decision date in May 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).
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