FDA 510(k) Clearances - 2022
3,190 medical devices cleared by the FDA in 2022. Data sourced from the FDA 510(k) public files.
2022 overview
The FDA cleared 3,190 medical devices in 2022 through the 510(k) premarket notification pathway, across 12 months of reported activity.
General Hospital was the leading specialty with 539 clearances - 17% of the annual total. The overall average review time was 185 days, ranging from 1 to 1192 days.
The most active manufacturers in 2022 were Siemens Medical Solutions USA, Inc. (30) , Arthrex, Inc. (17) , Boston Scientific Corporation (14) , Becton, Dickinson and Company (14) and Smith & Nephew, Inc. (13) .
Monthly clearances - 2022
Monthly breakdown
| Month | Cleared | Avg days | Min | Max | |
|---|---|---|---|---|---|
| January | 235 | 184 | 1 | 1002 | Report → |
| February | 203 | 179 | 1 | 810 | Report → |
| March | 288 | 185 | 2 | 722 | Report → |
| April | 257 | 176 | 14 | 915 | Report → |
| May | 286 | 187 | 14 | 788 | Report → |
| June | 279 | 188 | 1 | 828 | Report → |
| July | 255 | 183 | 1 | 767 | Report → |
| August | 255 | 190 | 1 | 1192 | Report → |
| September | 279 | 192 | 1 | 990 | Report → |
| October | 295 | 173 | 5 | 879 | Report → |
| November | 271 | 190 | 1 | 907 | Report → |
| December | 287 | 191 | 1 | 818 | Report → |
| Total 2022 | 3,190 | 185 | 1 | 1192 |
Clearances by specialty - 2022
| Specialty | Cleared | % of total | Avg days |
|---|---|---|---|
| General Hospital | 539 | 16.9% | 188 |
| Orthopedic | 477 | 15.0% | 157 |
| Radiology | 420 | 13.2% | 133 |
| General & Plastic Surgery | 404 | 12.7% | 174 |
| Cardiovascular | 294 | 9.2% | 183 |
| Dental | 250 | 7.8% | 217 |
| Gastroenterology & Urology | 154 | 4.8% | 186 |
| Neurology | 151 | 4.7% | 187 |
| Anesthesiology | 82 | 2.6% | 255 |
| Physical Medicine | 74 | 2.3% | 213 |
| Obstetrics & Gynecology | 73 | 2.3% | 176 |
| Ophthalmic | 60 | 1.9% | 187 |
| Microbiology | 59 | 1.8% | 251 |
| Chemistry | 54 | 1.7% | 366 |
| Ear, Nose, Throat | 47 | 1.5% | 160 |
| Immunology | 18 | 0.6% | 350 |
| Hematology | 16 | 0.5% | 473 |
| Toxicology | 10 | 0.3% | 247 |
| Pathology | 6 | 0.2% | 411 |
| Medical Genetics | 2 | 0.1% | 501 |
Monthly reports - 2022
About this data
This report covers FDA 510(k) submissions with a decision date in 2022. 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.