FDA 510(k) Clearances - January 2026
236 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
January 2026 overview
The FDA cleared 236 medical devices in January 2026 through the 510(k) premarket notification pathway. This compares to 289 clearances in December 2025 - a decrease of 53 (-18.3%).
Orthopedic led all specialties with 41 cleared devices. The fastest average review was Obstetrics & Gynecology at 93 days. The slowest was Ophthalmic at 261 days.
Overall average review time: 152 days, ranging from 1 to 452 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - January 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 December |
|---|---|---|---|---|---|
| Orthopedic | 41 | 121 | 25 | 300 | -1 |
| Radiology | 33 | 131 | 22 | 298 | -7 |
| General & Plastic Surgery | 31 | 143 | 28 | 334 | -10 |
| Cardiovascular | 30 | 162 | 29 | 452 | -1 |
| Dental | 19 | 163 | 1 | 421 | -4 |
| General Hospital | 14 | 206 | 118 | 305 | -6 |
| Gastroenterology & Urology | 14 | 163 | 30 | 280 | -2 |
| Neurology | 12 | 154 | 29 | 271 | -2 |
| Physical Medicine | 11 | 161 | 71 | 248 | +1 |
| Chemistry | 7 | 153 | 58 | 272 | - |
| Anesthesiology | 6 | 186 | 29 | 266 | -12 |
| Microbiology | 5 | 198 | 122 | 251 | -1 |
| Obstetrics & Gynecology | 3 | 93 | 57 | 136 | -6 |
| Toxicology | 3 | 197 | 115 | 318 | +2 |
| Immunology | 2 | 179 | 136 | 222 | -2 |
| Hematology | 2 | 149 | 30 | 268 | +2 |
| Ear, Nose, Throat | 2 | 192 | 165 | 219 | - |
| Ophthalmic | 1 | 261 | 261 | 261 | -3 |
| Total | 236 | 152 | 1 | 452 | -53 |
Key observations
Fastest reviews
The fastest individual clearance took 1 day. Reviews under 5 days typically reflect Special 510(k) submissions for minor modifications to already-cleared devices.
Longest review
The longest individual review reached 452 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 January 2026 with 41 clearances - 17% of all monthly clearances.
Review time spread
Ophthalmic posted the highest average at 261 days. Obstetrics & Gynecology was fastest at 93 days. The gap of 168 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in January 2026 were Medtronic, Inc. (3) , Boston Aesthetics, Inc. (3) , Medacta International S.A. (2) , Nova Biomedical Corporation (2) and Dongguan Smarfody Mobility Technology Co., Ltd. (2) . Together, these five manufacturers accounted for 12 of the 236 total clearances - 5% of all January activity.
About this data
This report covers FDA 510(k) submissions with a decision date in January 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.