FDA 510(k) Clearances - 2021
2,991 medical devices cleared by the FDA in 2021. Data sourced from the FDA 510(k) public files.
2021 overview
The FDA cleared 2,991 medical devices in 2021 through the 510(k) premarket notification pathway, across 12 months of reported activity.
General Hospital was the leading specialty with 625 clearances - 21% of the annual total. The overall average review time was 169 days, ranging from 1 to 1178 days.
The most active manufacturers in 2021 were Medacta International S.A. (25) , Siemens Medical Solutions USA, Inc. (24) , Boston Scientific Corporation (16) , Canon Medical Systems Corporation (15) and Smith & Nephew, Inc. (12) .
Monthly clearances - 2021
Monthly breakdown
| Month | Cleared | Avg days | Min | Max | |
|---|---|---|---|---|---|
| January | 200 | 172 | 23 | 686 | Report → |
| February | 228 | 171 | 8 | 1178 | Report → |
| March | 272 | 155 | 4 | 645 | Report → |
| April | 255 | 149 | 2 | 677 | Report → |
| May | 194 | 155 | 14 | 796 | Report → |
| June | 210 | 161 | 17 | 570 | Report → |
| July | 293 | 179 | 20 | 652 | Report → |
| August | 285 | 168 | 21 | 681 | Report → |
| September | 261 | 171 | 4 | 871 | Report → |
| October | 230 | 185 | 12 | 750 | Report → |
| November | 255 | 169 | 14 | 834 | Report → |
| December | 308 | 183 | 1 | 775 | Report → |
| Total 2021 | 2,991 | 169 | 1 | 1178 |
Clearances by specialty - 2021
| Specialty | Cleared | % of total | Avg days |
|---|---|---|---|
| General Hospital | 625 | 20.9% | 172 |
| Orthopedic | 459 | 15.3% | 127 |
| Radiology | 407 | 13.6% | 120 |
| General & Plastic Surgery | 301 | 10.1% | 171 |
| Cardiovascular | 269 | 9.0% | 161 |
| Dental | 225 | 7.5% | 197 |
| Neurology | 160 | 5.3% | 200 |
| Gastroenterology & Urology | 126 | 4.2% | 163 |
| Physical Medicine | 77 | 2.6% | 233 |
| Obstetrics & Gynecology | 73 | 2.4% | 197 |
| Anesthesiology | 72 | 2.4% | 228 |
| Microbiology | 46 | 1.5% | 273 |
| Chemistry | 42 | 1.4% | 331 |
| Ophthalmic | 40 | 1.3% | 149 |
| Ear, Nose, Throat | 34 | 1.1% | 144 |
| Toxicology | 16 | 0.5% | 306 |
| Immunology | 12 | 0.4% | 437 |
| Pathology | 5 | 0.2% | 289 |
| Hematology | 2 | 0.1% | 341 |
Monthly reports - 2021
About this data
This report covers FDA 510(k) submissions with a decision date in 2021. 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.