FDA 510(k) Clearances - July 2025
281 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
July 2025 overview
The FDA cleared 281 medical devices in July 2025 through the 510(k) premarket notification pathway. This compares to 294 clearances in June 2025 - a decrease of 13 (-4.4%).
Radiology led all specialties with 50 cleared devices. The fastest average review was Hematology at 44 days. The slowest was Toxicology at 239 days.
Overall average review time: 145 days, ranging from 3 to 779 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - July 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 June |
|---|---|---|---|---|---|
| Radiology | 50 | 142 | 20 | 300 | +17 |
| Orthopedic | 49 | 114 | 7 | 434 | +1 |
| General & Plastic Surgery | 40 | 127 | 10 | 276 | -3 |
| Cardiovascular | 32 | 178 | 23 | 462 | +2 |
| General Hospital | 21 | 145 | 25 | 275 | +1 |
| Neurology | 17 | 146 | 3 | 284 | +3 |
| Dental | 16 | 183 | 30 | 779 | -5 |
| Gastroenterology & Urology | 12 | 112 | 30 | 265 | -13 |
| Physical Medicine | 11 | 137 | 54 | 323 | +3 |
| Anesthesiology | 9 | 169 | 60 | 287 | -7 |
| Obstetrics & Gynecology | 6 | 145 | 21 | 266 | +3 |
| Microbiology | 6 | 226 | 141 | 268 | -8 |
| Ear, Nose, Throat | 3 | 222 | 179 | 259 | -3 |
| Chemistry | 3 | 173 | 89 | 329 | +1 |
| Ophthalmic | 3 | 218 | 143 | 313 | - |
| Hematology | 2 | 44 | 28 | 60 | -2 |
| Toxicology | 1 | 239 | 239 | 239 | - |
| Total | 281 | 145 | 3 | 779 | -13 |
Key observations
Fastest reviews
The fastest individual clearance took 3 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 779 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 July 2025 with 50 clearances - 18% of all monthly clearances.
Review time spread
Toxicology posted the highest average at 239 days. Hematology was fastest at 44 days. The gap of 195 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in July 2025 were Siemens Medical Solutions USA, Inc. (7) , Medacta International S.A. (5) , Intuitive Surgical, Inc. (4) , Arthrex, Inc. (3) and Olympus Medical Systems Corporation (3) . Together, these five manufacturers accounted for 22 of the 281 total clearances - 8% of all July activity.
About this data
This report covers FDA 510(k) submissions with a decision date in July 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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