FDA 510(k) Clearances - August 2025
253 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
August 2025 overview
The FDA cleared 253 medical devices in August 2025 through the 510(k) premarket notification pathway. This compares to 281 clearances in July 2025 - a decrease of 28 (-10.0%).
Orthopedic led all specialties with 38 cleared devices. The fastest average review was Toxicology at 42 days. The slowest was Pathology at 239 days.
Overall average review time: 148 days, ranging from 12 to 728 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - August 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 July |
|---|---|---|---|---|---|
| Orthopedic | 38 | 125 | 12 | 317 | -11 |
| General & Plastic Surgery | 37 | 139 | 25 | 331 | -3 |
| Radiology | 33 | 148 | 15 | 728 | -17 |
| Dental | 21 | 150 | 30 | 297 | +5 |
| Cardiovascular | 17 | 141 | 26 | 433 | -15 |
| Neurology | 16 | 144 | 28 | 276 | -1 |
| General Hospital | 15 | 157 | 20 | 282 | -6 |
| Anesthesiology | 14 | 203 | 108 | 482 | +5 |
| Microbiology | 14 | 139 | 55 | 272 | +8 |
| Obstetrics & Gynecology | 12 | 182 | 30 | 425 | +6 |
| Gastroenterology & Urology | 11 | 130 | 28 | 260 | -1 |
| Chemistry | 7 | 176 | 48 | 266 | +4 |
| Physical Medicine | 4 | 120 | 89 | 185 | -7 |
| Ear, Nose, Throat | 4 | 206 | 59 | 420 | +1 |
| Toxicology | 3 | 42 | 25 | 51 | +2 |
| Ophthalmic | 3 | 236 | 162 | 281 | - |
| Hematology | 3 | 112 | 108 | 117 | +1 |
| Pathology | 1 | 239 | 239 | 239 | +1 |
| Total | 253 | 148 | 12 | 728 | -28 |
Key observations
Fastest reviews
The fastest individual clearance took 12 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 728 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: Orthopedic
Orthopedic led August 2025 with 38 clearances - 15% of all monthly clearances.
Review time spread
Pathology posted the highest average at 239 days. Toxicology was fastest at 42 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 August 2025 were Dentsply Sirona, Inc. (4) , Beckman Coulter, Inc. (3) , Epic Medical Pte. , Ltd. (2) , Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2) and Stryker GmbH (2) . Together, these five manufacturers accounted for 13 of the 253 total clearances - 5% of all August activity.
About this data
This report covers FDA 510(k) submissions with a decision date in August 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.