FDA 510(k) Clearances - 2026
2,493 medical devices cleared by the FDA in 2026. Data sourced from the FDA 510(k) public files.
2026 overview
The FDA cleared 2,493 medical devices in 2026 through the 510(k) premarket notification pathway, across 10 months of reported activity.
Orthopedic was the leading specialty with 405 clearances - 16% of the annual total. The overall average review time was 152 days, ranging from 1 to 715 days.
The most active manufacturers in 2026 were Arthrex, Inc. (17) , Fujifilm Corporation (13) , Boston Scientific Corporation (13) , Karl Storz SE & CO. KG (13) and Roche Diagnostics (12) .
Monthly clearances - 2026
Monthly breakdown
| Month | Cleared | Avg days | Min | Max | |
|---|---|---|---|---|---|
| January | 236 | 152 | 1 | 452 | Report → |
| February | 215 | 150 | 19 | 466 | Report → |
| March | 283 | 140 | 1 | 706 | Report → |
| April | 312 | 155 | 1 | 635 | Report → |
| May | 276 | 154 | 16 | 417 | Report → |
| June | 306 | 170 | 1 | 613 | Report → |
| July | 275 | 127 | 1 | 404 | Report → |
| August | 238 | 154 | 6 | 447 | Report → |
| September | 315 | 160 | 14 | 715 | Report → |
| October partial | 37 | 156 | 28 | 366 | Report → |
| Total 2026 | 2,493 | 152 | 1 | 715 |
Clearances by specialty - 2026
| Specialty | Cleared | % of total | Avg days |
|---|---|---|---|
| Orthopedic | 405 | 16.2% | 125 |
| Radiology | 368 | 14.8% | 147 |
| General & Plastic Surgery | 307 | 12.3% | 141 |
| Cardiovascular | 269 | 10.8% | 157 |
| Dental | 177 | 7.1% | 148 |
| Neurology | 156 | 6.3% | 158 |
| Gastroenterology & Urology | 155 | 6.2% | 160 |
| General Hospital | 130 | 5.2% | 186 |
| Physical Medicine | 94 | 3.8% | 148 |
| Anesthesiology | 84 | 3.4% | 215 |
| Obstetrics & Gynecology | 81 | 3.2% | 177 |
| Microbiology | 73 | 2.9% | 141 |
| Chemistry | 58 | 2.3% | 146 |
| Ear, Nose, Throat | 51 | 2.0% | 149 |
| Ophthalmic | 35 | 1.4% | 163 |
| Immunology | 16 | 0.6% | 220 |
| Hematology | 13 | 0.5% | 232 |
| Pathology | 10 | 0.4% | 200 |
| Toxicology | 10 | 0.4% | 123 |
| Medical Genetics | 1 | 0.0% | 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.