FDA 510(k) Clearances - June 2026
75 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
The FDA publishes 510(k) clearance files on the 5th of each month, covering decisions through the previous month. June 2026 data is currently incomplete and will be fully updated after the July 6, 2026 sync. Stats and comparisons below reflect submissions recorded to date.
June 2026 overview
The FDA cleared 75 medical devices in June 2026 through the 510(k) premarket notification pathway. Full comparison with May will be available once June data is complete on July 6, 2026.
General & Plastic Surgery led all specialties with 14 cleared devices. The fastest average review was Ear, Nose, Throat at 25 days. The slowest was Gastroenterology & Urology at 192 days.
Overall average review time: 158 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 |
|---|---|---|---|---|
| General & Plastic Surgery | 14 | 191 | 29 | 368 |
| Orthopedic | 11 | 178 | 28 | 613 |
| General Hospital | 8 | 184 | 83 | 294 |
| Radiology | 8 | 153 | 28 | 258 |
| Neurology | 6 | 153 | 27 | 271 |
| Dental | 5 | 86 | 1 | 265 |
| Cardiovascular | 5 | 142 | 30 | 251 |
| Anesthesiology | 4 | 155 | 24 | 267 |
| Physical Medicine | 4 | 140 | 95 | 197 |
| Microbiology | 3 | 118 | 87 | 179 |
| Gastroenterology & Urology | 2 | 192 | 110 | 273 |
| Obstetrics & Gynecology | 2 | 166 | 73 | 258 |
| Ophthalmic | 1 | 182 | 182 | 182 |
| Chemistry | 1 | 26 | 26 | 26 |
| Ear, Nose, Throat | 1 | 25 | 25 | 25 |
| Total | 75 | 158 | 1 | 613 |
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: General & Plastic Surgery
General & Plastic Surgery led June 2026 with 14 clearances - 19% of all monthly clearances.
Review time spread
Gastroenterology & Urology posted the highest average at 192 days. Ear, Nose, Throat was fastest at 25 days. The gap of 167 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 Roosin Medical Co., Ltd. (2) , Taiwan Surgical Corporation (1) , Steps Ortho (1) , ResMed Corp (1) and Sonio (1) . Together, these five manufacturers accounted for 6 of the 75 total clearances - 8% 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).
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