FDA 510(k) Clearances - August 2026
238 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
August 2026 overview
The FDA cleared 238 medical devices in August 2026 through the 510(k) premarket notification pathway. This compares to 275 clearances in July 2026 - a decrease of 37 (-13.5%).
General & Plastic Surgery led all specialties with 32 cleared devices. The fastest average review was Chemistry at 108 days. The slowest was Hematology at 242 days.
Overall average review time: 155 days, ranging from 6 to 447 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - August 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 July |
|---|---|---|---|---|---|
| General & Plastic Surgery | 32 | 139 | 6 | 378 | +5 |
| Orthopedic | 31 | 113 | 16 | 290 | -16 |
| Radiology | 31 | 153 | 22 | 358 | -19 |
| Cardiovascular | 24 | 159 | 24 | 447 | -8 |
| Neurology | 22 | 121 | 28 | 265 | +7 |
| Gastroenterology & Urology | 19 | 164 | 21 | 331 | -1 |
| Dental | 16 | 176 | 58 | 444 | -2 |
| General Hospital | 12 | 161 | 25 | 410 | - |
| Anesthesiology | 10 | 204 | 52 | 440 | +2 |
| Obstetrics & Gynecology | 8 | 166 | 60 | 241 | +1 |
| Physical Medicine | 7 | 168 | 86 | 258 | -1 |
| Microbiology | 6 | 193 | 58 | 305 | -3 |
| Immunology | 5 | 212 | 90 | 324 | +3 |
| Ear, Nose, Throat | 5 | 210 | 141 | 322 | -2 |
| Ophthalmic | 4 | 211 | 29 | 305 | - |
| Pathology | 3 | 210 | 100 | 266 | -1 |
| Chemistry | 2 | 108 | 25 | 190 | -1 |
| Hematology | 1 | 242 | 242 | 242 | +1 |
| Total | 238 | 155 | 6 | 447 | -37 |
Key observations
Fastest reviews
The fastest individual clearance took 6 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 447 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 August 2026 with 32 clearances - 13% of all monthly clearances.
Review time spread
Hematology posted the highest average at 242 days. Chemistry was fastest at 108 days. The gap of 134 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in August 2026 were Olympus Medical Systems Corporation (3) , Paragon 28, Inc. (3) , Alembic, LLC (2) , Mediclus Co., Ltd. (2) and Zhengzhou PZ Laser Slim Technology Co., Ltd. (2) . Together, these five manufacturers accounted for 12 of the 238 total clearances - 5% of all August activity.
About this data
This report covers FDA 510(k) submissions with a decision date in August 2026 and a valid days-to-decision value. Data is sourced from the FDA 510(k) public files, published and last updated September 5, 2026 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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