FDA 510(k) Clearances - October 2026
37 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. October 2026 data is currently incomplete and will be fully updated after the November 6, 2026 sync. Stats and comparisons below reflect submissions recorded to date.
October 2026 overview
The FDA cleared 37 medical devices in October 2026 through the 510(k) premarket notification pathway. Full comparison with September will be available once October data is complete on November 6, 2026.
Orthopedic led all specialties with 9 cleared devices. The fastest average review was Orthopedic at 75 days. The slowest was Neurology at 298 days.
Overall average review time: 156 days, ranging from 28 to 366 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - October 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 | 9 | 75 | 28 | 171 |
| Radiology | 6 | 111 | 36 | 185 |
| Microbiology | 5 | 204 | 28 | 249 |
| Neurology | 4 | 298 | 266 | 366 |
| Cardiovascular | 3 | 98 | 28 | 231 |
| Gastroenterology & Urology | 3 | 162 | 126 | 231 |
| Chemistry | 2 | 223 | 213 | 232 |
| Dental | 2 | 269 | 269 | 269 |
| General Hospital | 2 | 110 | 93 | 126 |
| Anesthesiology | 1 | 231 | 231 | 231 |
| Total | 37 | 156 | 28 | 366 |
Key observations
Fastest reviews
The fastest individual clearance took 28 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 366 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 October 2026 with 9 clearances - 24% of all monthly clearances.
Review time spread
Neurology posted the highest average at 298 days. Orthopedic was fastest at 75 days. The gap of 223 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in October 2026 were Roche Diagnostics (3) , Tdm Co., Ltd. (2) , OsteoCentric Technologies (1) , Yty Industry (Manjung) Sdn Bhd (1) and Airs Medical, Inc. (1) . Together, these five manufacturers accounted for 8 of the 37 total clearances - 22% of all October activity.
About this data
This report covers FDA 510(k) submissions with a decision date in October 2026 and a valid days-to-decision value. Data is sourced from the FDA 510(k) public files, published and last updated October 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).
Maintained by Space Bits, S.L. Not affiliated with or endorsed by the FDA. Verify at accessdata.fda.gov.