FDA 510(k) Clearances - October 2025
304 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
October 2025 overview
The FDA cleared 304 medical devices in October 2025 through the 510(k) premarket notification pathway. This compares to 257 clearances in September 2025 - an increase of 47 (+18.3%).
General & Plastic Surgery led all specialties with 59 cleared devices. The fastest average review was Hematology at 28 days. The slowest was Immunology at 213 days.
Overall average review time: 135 days, ranging from 1 to 846 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - October 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 September |
|---|---|---|---|---|---|
| General & Plastic Surgery | 59 | 126 | 15 | 455 | +32 |
| Orthopedic | 49 | 102 | 14 | 397 | +19 |
| Radiology | 36 | 153 | 21 | 271 | -8 |
| Cardiovascular | 33 | 121 | 20 | 317 | +5 |
| Gastroenterology & Urology | 27 | 148 | 24 | 342 | +6 |
| Dental | 26 | 124 | 1 | 375 | +4 |
| Neurology | 17 | 199 | 57 | 846 | +1 |
| General Hospital | 15 | 162 | 29 | 303 | +5 |
| Microbiology | 10 | 152 | 87 | 266 | - |
| Obstetrics & Gynecology | 8 | 130 | 24 | 367 | -2 |
| Physical Medicine | 6 | 121 | 29 | 281 | -1 |
| Chemistry | 5 | 157 | 73 | 270 | +1 |
| Anesthesiology | 4 | 173 | 28 | 258 | -6 |
| Immunology | 4 | 213 | 90 | 269 | +3 |
| Ophthalmic | 3 | 164 | 113 | 239 | -4 |
| Toxicology | 1 | 30 | 30 | 30 | -2 |
| Hematology | 1 | 28 | 28 | 28 | - |
| Total | 304 | 135 | 1 | 846 | +47 |
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 846 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: General & Plastic Surgery
General & Plastic Surgery led October 2025 with 59 clearances - 19% of all monthly clearances.
Review time spread
Immunology posted the highest average at 213 days. Hematology was fastest at 28 days. The gap of 185 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in October 2025 were Olympus Medical Systems Corporation (6) , Maxx Orthopedics, Inc. (3) , Boston Scientific Corporation (3) , Terrats Medical SL (2) and ACON Laboratories, Inc. (2) . Together, these five manufacturers accounted for 16 of the 304 total clearances - 5% of all October activity.
About this data
This report covers FDA 510(k) submissions with a decision date in October 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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