FDA 510(k) Clearances - September 2025
257 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
September 2025 overview
The FDA cleared 257 medical devices in September 2025 through the 510(k) premarket notification pathway. This compares to 253 clearances in August 2025 - an increase of 4 (+1.6%).
Radiology led all specialties with 44 cleared devices. The fastest average review was Hematology at 26 days. The slowest was Pathology at 449 days.
Overall average review time: 140 days, ranging from 1 to 796 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - September 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 August |
|---|---|---|---|---|---|
| Radiology | 44 | 152 | 22 | 402 | +11 |
| Orthopedic | 30 | 98 | 28 | 258 | -8 |
| Cardiovascular | 28 | 137 | 28 | 349 | +11 |
| General & Plastic Surgery | 27 | 158 | 33 | 796 | -10 |
| Dental | 22 | 167 | 1 | 410 | +1 |
| Gastroenterology & Urology | 21 | 144 | 28 | 273 | +10 |
| Neurology | 16 | 113 | 28 | 279 | - |
| Obstetrics & Gynecology | 10 | 147 | 31 | 242 | -2 |
| Microbiology | 10 | 150 | 84 | 267 | -4 |
| Anesthesiology | 10 | 186 | 14 | 290 | -4 |
| General Hospital | 10 | 105 | 29 | 249 | -5 |
| Physical Medicine | 7 | 120 | 48 | 245 | +3 |
| Ophthalmic | 7 | 131 | 30 | 273 | +4 |
| Ear, Nose, Throat | 5 | 90 | 25 | 161 | +1 |
| Chemistry | 4 | 161 | 27 | 265 | -3 |
| Toxicology | 3 | 87 | 30 | 199 | - |
| Immunology | 1 | 218 | 218 | 218 | +1 |
| Hematology | 1 | 26 | 26 | 26 | -2 |
| Pathology | 1 | 449 | 449 | 449 | - |
| Total | 257 | 140 | 1 | 796 | +4 |
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 796 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 September 2025 with 44 clearances - 17% of all monthly clearances.
Review time spread
Pathology posted the highest average at 449 days. Hematology was fastest at 26 days. The gap of 423 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in September 2025 were Intuitive Surgical, Inc. (4) , Shanghai United Imaging Healthcare Co., Ltd. (4) , Boston Scientific Corporation (3) , Olympus Medical Systems Corporation (3) and Medacta International S.A. (3) . Together, these five manufacturers accounted for 17 of the 257 total clearances - 7% of all September activity.
About this data
This report covers FDA 510(k) submissions with a decision date in September 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.