FDA 510(k) Clearances - 2023
3,300 medical devices cleared by the FDA in 2023. Data sourced from the FDA 510(k) public files.
2023 overview
The FDA cleared 3,300 medical devices in 2023 through the 510(k) premarket notification pathway, across 12 months of reported activity.
Orthopedic was the leading specialty with 569 clearances - 17% of the annual total. The overall average review time was 176 days, ranging from 1 to 1356 days.
The most active manufacturers in 2023 were Siemens Medical Solutions USA, Inc. (24) , Boston Scientific Corporation (20) , Arthrex, Inc. (18) , STERIS Corporation (17) and Medacta International S.A. (14) .
Monthly clearances - 2023
Monthly breakdown
| Month | Cleared | Avg days | Min | Max | |
|---|---|---|---|---|---|
| January | 200 | 196 | 12 | 1356 | Report → |
| February | 251 | 185 | 6 | 832 | Report → |
| March | 317 | 193 | 2 | 1127 | Report → |
| April | 231 | 179 | 15 | 1211 | Report → |
| May | 264 | 191 | 2 | 957 | Report → |
| June | 301 | 182 | 1 | 1139 | Report → |
| July | 251 | 176 | 1 | 854 | Report → |
| August | 309 | 173 | 1 | 723 | Report → |
| September | 309 | 189 | 1 | 1278 | Report → |
| October | 309 | 153 | 10 | 864 | Report → |
| November | 250 | 148 | 1 | 537 | Report → |
| December | 308 | 156 | 1 | 649 | Report → |
| Total 2023 | 3,300 | 176 | 1 | 1356 |
Clearances by specialty - 2023
| Specialty | Cleared | % of total | Avg days |
|---|---|---|---|
| Orthopedic | 569 | 17.2% | 132 |
| Radiology | 451 | 13.7% | 148 |
| General & Plastic Surgery | 412 | 12.5% | 173 |
| General Hospital | 331 | 10.0% | 193 |
| Cardiovascular | 325 | 9.8% | 149 |
| Dental | 237 | 7.2% | 192 |
| Gastroenterology & Urology | 182 | 5.5% | 174 |
| Neurology | 178 | 5.4% | 177 |
| Anesthesiology | 109 | 3.3% | 310 |
| Chemistry | 92 | 2.8% | 282 |
| Microbiology | 92 | 2.8% | 202 |
| Physical Medicine | 80 | 2.4% | 213 |
| Obstetrics & Gynecology | 72 | 2.2% | 183 |
| Ophthalmic | 54 | 1.6% | 174 |
| Ear, Nose, Throat | 46 | 1.4% | 181 |
| Hematology | 24 | 0.7% | 318 |
| Immunology | 22 | 0.7% | 330 |
| Toxicology | 18 | 0.5% | 182 |
| Pathology | 4 | 0.1% | 385 |
| Medical Genetics | 2 | 0.1% | 673 |
Monthly reports - 2023
About this data
This report covers FDA 510(k) submissions with a decision date in 2023. 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.