FDA 510(k) Clearances - May 2026
19 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. May 2026 data is currently incomplete and will be fully updated after the June 6, 2026 sync. Stats and comparisons below reflect submissions recorded to date.
May 2026 overview
The FDA cleared 19 medical devices in May 2026 through the 510(k) premarket notification pathway. Full comparison with April will be available once May data is complete on June 6, 2026.
Orthopedic led all specialties with 5 cleared devices. The fastest average review was Cardiovascular at 30 days. The slowest was Neurology at 216 days.
Overall average review time: 158 days, ranging from 30 to 303 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 |
|---|---|---|---|---|
| Orthopedic | 5 | 174 | 130 | 254 |
| Chemistry | 3 | 192 | 43 | 267 |
| Dental | 2 | 176 | 49 | 303 |
| Neurology | 2 | 216 | 162 | 270 |
| General & Plastic Surgery | 2 | 77 | 31 | 123 |
| Anesthesiology | 2 | 186 | 148 | 224 |
| Gastroenterology & Urology | 1 | 91 | 91 | 91 |
| Microbiology | 1 | 130 | 130 | 130 |
| Cardiovascular | 1 | 30 | 30 | 30 |
| Total | 19 | 158 | 30 | 303 |
Key observations
Fastest reviews
The fastest individual clearance took 30 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 303 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 May 2026 with 5 clearances - 26% of all monthly clearances.
Review time spread
Neurology posted the highest average at 216 days. Cardiovascular was fastest at 30 days. The gap of 186 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 Radiometer Medicals Aps (2) , Dongguan Tutamen Metalwork Co., Ltd. (1) , ArthroTAK, LLC (1) , Philips Medizin Systeme (1) and Mediclus Co., Ltd. (1) . Together, these five manufacturers accounted for 6 of the 19 total clearances - 32% 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).
Maintained by Space Bits, S.L. Not affiliated with or endorsed by the FDA. Verify at accessdata.fda.gov.