FDA 510(k) Clearances - 2025
3,195 medical devices cleared by the FDA in 2025. Data sourced from the FDA 510(k) public files.
2025 overview
The FDA cleared 3,195 medical devices in 2025 through the 510(k) premarket notification pathway, across 12 months of reported activity.
Orthopedic was the leading specialty with 482 clearances - 15% of the annual total. The overall average review time was 146 days, ranging from 1 to 865 days.
The most active manufacturers in 2025 were Olympus Medical Systems Corporation (22) , Arthrex, Inc. (21) , Intuitive Surgical, Inc. (21) , Shanghai United Imaging Healthcare Co., Ltd. (17) and Medacta International S.A. (15) .
Monthly clearances - 2025
Monthly breakdown
| Month | Cleared | Avg days | Min | Max | |
|---|---|---|---|---|---|
| January | 254 | 150 | 1 | 634 | Report → |
| February | 234 | 147 | 1 | 438 | Report → |
| March | 244 | 143 | 3 | 574 | Report → |
| April | 282 | 141 | 4 | 573 | Report → |
| May | 299 | 151 | 1 | 587 | Report → |
| June | 294 | 149 | 18 | 450 | Report → |
| July | 281 | 145 | 3 | 779 | Report → |
| August | 253 | 148 | 12 | 728 | Report → |
| September | 257 | 140 | 1 | 796 | Report → |
| October | 304 | 135 | 1 | 846 | Report → |
| November | 204 | 151 | 1 | 459 | Report → |
| December | 289 | 156 | 1 | 865 | Report → |
| Total 2025 | 3,195 | 146 | 1 | 865 |
Clearances by specialty - 2025
| Specialty | Cleared | % of total | Avg days |
|---|---|---|---|
| Orthopedic | 482 | 15.1% | 115 |
| Radiology | 467 | 14.6% | 155 |
| General & Plastic Surgery | 440 | 13.8% | 131 |
| Cardiovascular | 301 | 9.4% | 148 |
| Dental | 242 | 7.6% | 151 |
| Neurology | 209 | 6.5% | 152 |
| Gastroenterology & Urology | 206 | 6.4% | 153 |
| General Hospital | 200 | 6.3% | 146 |
| Microbiology | 123 | 3.8% | 166 |
| Anesthesiology | 122 | 3.8% | 190 |
| Physical Medicine | 102 | 3.2% | 149 |
| Obstetrics & Gynecology | 94 | 2.9% | 162 |
| Chemistry | 54 | 1.7% | 168 |
| Ear, Nose, Throat | 44 | 1.4% | 171 |
| Ophthalmic | 40 | 1.3% | 170 |
| Hematology | 22 | 0.7% | 120 |
| Toxicology | 18 | 0.6% | 88 |
| Immunology | 16 | 0.5% | 206 |
| Pathology | 13 | 0.4% | 225 |
Monthly reports - 2025
About this data
This report covers FDA 510(k) submissions with a decision date in 2025. 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.