FDA 510(k) Clearances - February 2026
215 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
February 2026 overview
The FDA cleared 215 medical devices in February 2026 through the 510(k) premarket notification pathway. This compares to 236 clearances in January 2026 - a decrease of 21 (-8.9%).
Orthopedic led all specialties with 42 cleared devices. The fastest average review was Physical Medicine at 117 days. The slowest was Hematology at 466 days.
Overall average review time: 150 days, ranging from 19 to 466 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - February 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 January |
|---|---|---|---|---|---|
| Orthopedic | 42 | 125 | 22 | 336 | +1 |
| General & Plastic Surgery | 36 | 135 | 19 | 424 | +5 |
| Cardiovascular | 29 | 149 | 28 | 382 | -1 |
| Radiology | 28 | 121 | 20 | 269 | -5 |
| General Hospital | 14 | 180 | 30 | 286 | - |
| Obstetrics & Gynecology | 9 | 179 | 59 | 274 | +6 |
| Dental | 9 | 182 | 91 | 276 | -10 |
| Gastroenterology & Urology | 9 | 214 | 81 | 357 | -5 |
| Chemistry | 8 | 144 | 71 | 262 | +1 |
| Neurology | 8 | 176 | 28 | 267 | -4 |
| Physical Medicine | 6 | 117 | 89 | 244 | -5 |
| Anesthesiology | 4 | 197 | 143 | 269 | -2 |
| Ear, Nose, Throat | 4 | 155 | 93 | 256 | +2 |
| Microbiology | 3 | 145 | 90 | 252 | -2 |
| Ophthalmic | 3 | 179 | 58 | 266 | +2 |
| Immunology | 1 | 410 | 410 | 410 | -1 |
| Toxicology | 1 | 185 | 185 | 185 | -2 |
| Hematology | 1 | 466 | 466 | 466 | -1 |
| Total | 215 | 150 | 19 | 466 | -21 |
Key observations
Fastest reviews
The fastest individual clearance took 19 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 466 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 February 2026 with 42 clearances - 20% of all monthly clearances.
Review time spread
Hematology posted the highest average at 466 days. Physical Medicine was fastest at 117 days. The gap of 349 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in February 2026 were Siemens Healthcare Diagnostics, Inc. (2) , Shenzhen TPH Technology Co., Ltd. (2) , Ge Medical Systems, LLC (2) , Fujifilm Corporation (2) and Medacta International S.A. (2) . Together, these five manufacturers accounted for 10 of the 215 total clearances - 5% of all February activity.
About this data
This report covers FDA 510(k) submissions with a decision date in February 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.