FDA 510(k) Clearances - 2024
3,082 medical devices cleared by the FDA in 2024. Data sourced from the FDA 510(k) public files.
2024 overview
The FDA cleared 3,082 medical devices in 2024 through the 510(k) premarket notification pathway, across 12 months of reported activity.
Orthopedic was the leading specialty with 516 clearances - 17% of the annual total. The overall average review time was 159 days, ranging from 1 to 1318 days.
The most active manufacturers in 2024 were Siemens Medical Solutions USA, Inc. (22) , Beckman Coulter, Inc. (18) , Intuitive Surgical, Inc. (12) , Shanghai United Imaging Healthcare Co., Ltd. (12) and Varian Medical Systems, Inc. (11) .
Monthly clearances - 2024
Monthly breakdown
| Month | Cleared | Avg days | Min | Max | |
|---|---|---|---|---|---|
| January | 209 | 166 | 27 | 762 | Report → |
| February | 214 | 151 | 1 | 791 | Report → |
| March | 278 | 153 | 1 | 1079 | Report → |
| April | 246 | 177 | 1 | 1318 | Report → |
| May | 275 | 173 | 7 | 872 | Report → |
| June | 260 | 167 | 14 | 746 | Report → |
| July | 247 | 143 | 17 | 1073 | Report → |
| August | 280 | 157 | 1 | 1056 | Report → |
| September | 228 | 176 | 7 | 1281 | Report → |
| October | 293 | 146 | 7 | 1212 | Report → |
| November | 258 | 154 | 2 | 1279 | Report → |
| December | 294 | 147 | 1 | 809 | Report → |
| Total 2024 | 3,082 | 159 | 1 | 1318 |
Clearances by specialty - 2024
| Specialty | Cleared | % of total | Avg days |
|---|---|---|---|
| Orthopedic | 516 | 16.7% | 114 |
| General & Plastic Surgery | 435 | 14.1% | 151 |
| Radiology | 413 | 13.4% | 139 |
| Cardiovascular | 281 | 9.1% | 149 |
| Dental | 268 | 8.7% | 183 |
| General Hospital | 221 | 7.2% | 170 |
| Gastroenterology & Urology | 180 | 5.8% | 155 |
| Neurology | 167 | 5.4% | 170 |
| Anesthesiology | 101 | 3.3% | 258 |
| Physical Medicine | 97 | 3.1% | 165 |
| Microbiology | 84 | 2.7% | 246 |
| Obstetrics & Gynecology | 83 | 2.7% | 180 |
| Chemistry | 76 | 2.5% | 242 |
| Ophthalmic | 55 | 1.8% | 177 |
| Ear, Nose, Throat | 36 | 1.2% | 157 |
| Toxicology | 28 | 0.9% | 86 |
| Immunology | 17 | 0.6% | 188 |
| Pathology | 12 | 0.4% | 244 |
| Hematology | 12 | 0.4% | 187 |
Monthly reports - 2024
About this data
This report covers FDA 510(k) submissions with a decision date in 2024. 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.