FDA 510(k) Clearances - 2026
1,903 medical devices cleared by the FDA in 2026. Data sourced from the FDA 510(k) public files.
2026 overview
The FDA cleared 1,903 medical devices in 2026 through the 510(k) premarket notification pathway, across 7 months of reported activity.
Orthopedic was the leading specialty with 320 clearances - 17% of the annual total. The overall average review time was 150 days, ranging from 1 to 706 days.
The most active manufacturers in 2026 were Arthrex, Inc. (13) , Boston Scientific Corporation (10) , Siemens Medical Solutions USA, Inc. (9) , Fujifilm Corporation (8) and ZheJiang Decans Medical Devices Co., Ltd. (8) .
Monthly clearances - 2026
Monthly breakdown
Clearances by specialty - 2026
| Specialty | Cleared | % of total | Avg days |
|---|---|---|---|
| Orthopedic | 320 | 16.8% | 128 |
| Radiology | 289 | 15.2% | 146 |
| General & Plastic Surgery | 236 | 12.4% | 136 |
| Cardiovascular | 205 | 10.8% | 150 |
| Dental | 135 | 7.1% | 144 |
| Neurology | 112 | 5.9% | 158 |
| Gastroenterology & Urology | 109 | 5.7% | 161 |
| General Hospital | 101 | 5.3% | 196 |
| Physical Medicine | 71 | 3.7% | 143 |
| Anesthesiology | 64 | 3.4% | 211 |
| Obstetrics & Gynecology | 62 | 3.3% | 174 |
| Microbiology | 52 | 2.7% | 131 |
| Chemistry | 44 | 2.3% | 151 |
| Ear, Nose, Throat | 40 | 2.1% | 138 |
| Ophthalmic | 27 | 1.4% | 164 |
| Hematology | 10 | 0.5% | 235 |
| Immunology | 10 | 0.5% | 225 |
| Toxicology | 9 | 0.5% | 122 |
| Pathology | 6 | 0.3% | 184 |
| Medical Genetics | 1 | 0.1% | 349 |
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.