FDA 510(k) Clearances - June 2025
294 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
June 2025 overview
The FDA cleared 294 medical devices in June 2025 through the 510(k) premarket notification pathway. This compares to 299 clearances in May 2025 - a decrease of 5 (-1.7%).
Orthopedic led all specialties with 48 cleared devices. The fastest average review was Toxicology at 20 days. The slowest was Chemistry at 268 days.
Overall average review time: 149 days, ranging from 18 to 450 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - June 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 May |
|---|---|---|---|---|---|
| Orthopedic | 48 | 114 | 18 | 294 | +8 |
| General & Plastic Surgery | 43 | 142 | 22 | 440 | +11 |
| Radiology | 33 | 140 | 21 | 266 | -15 |
| Cardiovascular | 30 | 147 | 30 | 450 | +1 |
| Gastroenterology & Urology | 25 | 176 | 53 | 278 | +1 |
| Dental | 21 | 140 | 28 | 271 | -11 |
| General Hospital | 20 | 146 | 25 | 269 | - |
| Anesthesiology | 16 | 165 | 27 | 324 | +5 |
| Microbiology | 14 | 162 | 83 | 273 | +5 |
| Neurology | 14 | 183 | 27 | 379 | -4 |
| Physical Medicine | 8 | 177 | 29 | 439 | -2 |
| Ear, Nose, Throat | 6 | 169 | 28 | 266 | +1 |
| Hematology | 4 | 119 | 54 | 270 | +1 |
| Ophthalmic | 3 | 229 | 157 | 267 | +2 |
| Obstetrics & Gynecology | 3 | 254 | 215 | 279 | -5 |
| Pathology | 2 | 160 | 81 | 238 | - |
| Chemistry | 2 | 268 | 266 | 269 | -2 |
| Immunology | 1 | 267 | 267 | 267 | -2 |
| Toxicology | 1 | 20 | 20 | 20 | +1 |
| Total | 294 | 149 | 18 | 450 | -5 |
Key observations
Fastest reviews
The fastest individual clearance took 18 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 450 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 June 2025 with 48 clearances - 16% of all monthly clearances.
Review time spread
Chemistry posted the highest average at 268 days. Toxicology was fastest at 20 days. The gap of 248 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in June 2025 were Brainlab AG (3) , Sysmex America, Inc. (3) , Intuitive Surgical, Inc. (2) , PAJUNK GmbH Medizintechnologie (2) and Thermo Fisher Scientific (2) . Together, these five manufacturers accounted for 12 of the 294 total clearances - 4% of all June activity.
About this data
This report covers FDA 510(k) submissions with a decision date in June 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.