FDA 510(k) Clearances - November 2025
204 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
November 2025 overview
The FDA cleared 204 medical devices in November 2025 through the 510(k) premarket notification pathway. This compares to 304 clearances in October 2025 - a decrease of 100 (-32.9%).
Radiology led all specialties with 34 cleared devices. The fastest average review was Pathology at 88 days. The slowest was Microbiology at 195 days.
Overall average review time: 151 days, ranging from 1 to 459 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - November 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 October |
|---|---|---|---|---|---|
| Radiology | 34 | 149 | 23 | 282 | -2 |
| General & Plastic Surgery | 32 | 129 | 44 | 447 | -27 |
| Orthopedic | 29 | 140 | 54 | 446 | -20 |
| Neurology | 20 | 188 | 61 | 403 | +3 |
| Dental | 18 | 131 | 1 | 256 | -8 |
| Cardiovascular | 16 | 170 | 55 | 459 | -17 |
| General Hospital | 12 | 151 | 48 | 259 | -3 |
| Microbiology | 10 | 195 | 57 | 426 | - |
| Physical Medicine | 9 | 141 | 23 | 268 | +3 |
| Gastroenterology & Urology | 7 | 149 | 49 | 269 | -20 |
| Anesthesiology | 6 | 187 | 168 | 260 | +2 |
| Chemistry | 4 | 134 | 44 | 236 | -1 |
| Obstetrics & Gynecology | 3 | 127 | 99 | 154 | -5 |
| Ophthalmic | 2 | 157 | 46 | 267 | -1 |
| Toxicology | 1 | 97 | 97 | 97 | - |
| Pathology | 1 | 88 | 88 | 88 | +1 |
| Total | 204 | 151 | 1 | 459 | -100 |
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 459 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 November 2025 with 34 clearances - 17% of all monthly clearances.
Review time spread
Microbiology posted the highest average at 195 days. Pathology was fastest at 88 days. The gap of 107 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in November 2025 were Siemens Medical Solutions USA, Inc. (3) , Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. (3) , Roche Molecular Systems, Inc. (3) , Karl Storz SE & CO. KG (2) and Fresenius Medical Care Renal Therapies Group, LLC (2) . Together, these five manufacturers accounted for 13 of the 204 total clearances - 6% of all November activity.
About this data
This report covers FDA 510(k) submissions with a decision date in November 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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