FDA 510(k) Clearances - 2026
1,628 medical devices cleared by the FDA in 2026. Data sourced from the FDA 510(k) public files.
2026 overview
The FDA cleared 1,628 medical devices in 2026 through the 510(k) premarket notification pathway, across 6 months of reported activity.
Orthopedic was the leading specialty with 273 clearances - 17% of the annual total. The overall average review time was 154 days, ranging from 1 to 706 days.
The most active manufacturers in 2026 were Arthrex, Inc. (12) , Siemens Medical Solutions USA, Inc. (9) , Roche Diagnostics (8) , ZheJiang Decans Medical Devices Co., Ltd. (8) and Zimmer, Inc. (8) .
Monthly clearances - 2026
Monthly breakdown
Clearances by specialty - 2026
| Specialty | Cleared | % of total | Avg days |
|---|---|---|---|
| Orthopedic | 273 | 16.8% | 131 |
| Radiology | 239 | 14.7% | 148 |
| General & Plastic Surgery | 209 | 12.8% | 139 |
| Cardiovascular | 173 | 10.6% | 155 |
| Dental | 117 | 7.2% | 149 |
| Neurology | 97 | 6.0% | 155 |
| Gastroenterology & Urology | 89 | 5.5% | 170 |
| General Hospital | 89 | 5.5% | 206 |
| Physical Medicine | 63 | 3.9% | 145 |
| Anesthesiology | 56 | 3.4% | 220 |
| Obstetrics & Gynecology | 55 | 3.4% | 179 |
| Microbiology | 43 | 2.6% | 136 |
| Chemistry | 41 | 2.5% | 158 |
| Ear, Nose, Throat | 33 | 2.0% | 133 |
| Ophthalmic | 23 | 1.4% | 172 |
| Hematology | 10 | 0.6% | 235 |
| Immunology | 8 | 0.5% | 249 |
| Toxicology | 8 | 0.5% | 133 |
| Pathology | 2 | 0.1% | 121 |
Monthly reports - 2026
About this data
This report covers FDA 510(k) submissions with a decision date in 2026. Data is sourced from the FDA 510(k) public files, 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.