FDA 510(k) Clearances - May 2026
276 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
May 2026 overview
The FDA cleared 276 medical devices in May 2026 through the 510(k) premarket notification pathway. This compares to 312 clearances in April 2026 - a decrease of 36 (-11.5%).
Radiology led all specialties with 47 cleared devices. The fastest average review was Toxicology at 35 days. The slowest was Immunology at 272 days.
Overall average review time: 154 days, ranging from 16 to 417 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - May 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 April |
|---|---|---|---|---|---|
| Radiology | 47 | 143 | 23 | 274 | +8 |
| Orthopedic | 44 | 141 | 16 | 390 | -2 |
| General & Plastic Surgery | 42 | 132 | 27 | 406 | +16 |
| Dental | 20 | 138 | 37 | 303 | -2 |
| Gastroenterology & Urology | 18 | 170 | 32 | 289 | -5 |
| Cardiovascular | 18 | 166 | 30 | 274 | -26 |
| Neurology | 16 | 180 | 71 | 274 | - |
| Anesthesiology | 14 | 204 | 50 | 332 | +3 |
| General Hospital | 12 | 231 | 68 | 267 | -8 |
| Physical Medicine | 8 | 160 | 76 | 302 | -4 |
| Microbiology | 8 | 136 | 56 | 176 | -4 |
| Obstetrics & Gynecology | 7 | 165 | 132 | 258 | -6 |
| Ear, Nose, Throat | 6 | 150 | 89 | 270 | -1 |
| Ophthalmic | 5 | 110 | 29 | 233 | - |
| Chemistry | 5 | 152 | 27 | 267 | -5 |
| Immunology | 2 | 272 | 127 | 417 | +1 |
| Pathology | 2 | 121 | 106 | 136 | +2 |
| Toxicology | 1 | 35 | 35 | 35 | - |
| Hematology | 1 | 240 | 240 | 240 | -3 |
| Total | 276 | 154 | 16 | 417 | -36 |
Key observations
Fastest reviews
The fastest individual clearance took 16 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 417 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: Radiology
Radiology led May 2026 with 47 clearances - 17% of all monthly clearances.
Review time spread
Immunology posted the highest average at 272 days. Toxicology was fastest at 35 days. The gap of 237 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in May 2026 were ZheJiang Decans Medical Devices Co., Ltd. (3) , L & K Biomed Co., Ltd. (3) , Philips Ultrasound, LLC (3) , Shenzhen Root Innovation Technology Co., Ltd. (2) and Radiometer Medicals Aps (2) . Together, these five manufacturers accounted for 13 of the 276 total clearances - 5% of all May activity.
About this data
This report covers FDA 510(k) submissions with a decision date in May 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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