FDA 510(k) Clearances - June 2026
306 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
June 2026 overview
The FDA cleared 306 medical devices in June 2026 through the 510(k) premarket notification pathway. This compares to 276 clearances in May 2026 - an increase of 30 (+10.9%).
Orthopedic led all specialties with 45 cleared devices. The fastest average review was Hematology at 77 days. The slowest was Anesthesiology at 254 days.
Overall average review time: 170 days, ranging from 1 to 613 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - June 2026
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 | 45 | 161 | 25 | 613 | +1 |
| General & Plastic Surgery | 41 | 166 | 8 | 368 | -1 |
| Radiology | 40 | 177 | 27 | 448 | -7 |
| Cardiovascular | 31 | 148 | 12 | 286 | +13 |
| Neurology | 25 | 159 | 26 | 460 | +9 |
| Dental | 24 | 170 | 1 | 458 | +4 |
| General Hospital | 20 | 194 | 83 | 393 | +8 |
| Obstetrics & Gynecology | 15 | 221 | 52 | 532 | +8 |
| Physical Medicine | 14 | 143 | 63 | 268 | +6 |
| Anesthesiology | 13 | 254 | 24 | 408 | -1 |
| Gastroenterology & Urology | 9 | 184 | 60 | 273 | -9 |
| Ear, Nose, Throat | 8 | 102 | 14 | 264 | +2 |
| Chemistry | 8 | 139 | 26 | 322 | +3 |
| Microbiology | 7 | 171 | 87 | 270 | -1 |
| Ophthalmic | 3 | 171 | 62 | 269 | -2 |
| Immunology | 2 | 204 | 140 | 268 | - |
| Hematology | 1 | 77 | 77 | 77 | - |
| Total | 306 | 170 | 1 | 613 | +30 |
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 613 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 2026 with 45 clearances - 15% of all monthly clearances.
Review time spread
Anesthesiology posted the highest average at 254 days. Hematology was fastest at 77 days. The gap of 177 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in June 2026 were Siemens Medical Solutions USA, Inc. (3) , Tyber Medical, LLC (2) , Arthrex, Inc. (2) , Depuy Ireland UC (2) and Orthocon, Inc. (2) . Together, these five manufacturers accounted for 11 of the 306 total clearances - 4% of all June activity.
About this data
This report covers FDA 510(k) submissions with a decision date in June 2026 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.