FDA 510(k) Clearances - December 2022
287 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
December 2022 overview
The FDA cleared 287 medical devices in December 2022 through the 510(k) premarket notification pathway. This compares to 271 clearances in November 2022 - an increase of 16 (+5.9%).
Orthopedic led all specialties with 45 cleared devices. The fastest average review was Neurology at 124 days. The slowest was Pathology at 718 days.
Overall average review time: 191 days, ranging from 1 to 818 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - December 2022
Detailed data
Review time in calendar days from FDA receipt to decision. Source: FDA 510(k) downloadable files.
| Specialty | Cleared | Avg days | Min | Max | vs November |
|---|---|---|---|---|---|
| Orthopedic | 45 | 157 | 16 | 448 | +5 |
| General Hospital | 37 | 176 | 30 | 546 | -7 |
| Cardiovascular | 34 | 200 | 28 | 695 | +14 |
| Radiology | 32 | 153 | 17 | 522 | -3 |
| General & Plastic Surgery | 29 | 164 | 23 | 445 | -13 |
| Dental | 26 | 257 | 1 | 818 | +1 |
| Anesthesiology | 16 | 262 | 120 | 435 | +10 |
| Gastroenterology & Urology | 13 | 219 | 25 | 478 | +1 |
| Neurology | 13 | 124 | 27 | 529 | +1 |
| Chemistry | 7 | 273 | 59 | 622 | +3 |
| Obstetrics & Gynecology | 6 | 197 | 91 | 346 | - |
| Physical Medicine | 6 | 167 | 86 | 451 | +5 |
| Microbiology | 5 | 197 | 30 | 344 | +1 |
| Ophthalmic | 4 | 139 | 29 | 267 | -5 |
| Ear, Nose, Throat | 4 | 226 | 63 | 447 | -1 |
| Hematology | 4 | 254 | 29 | 589 | +2 |
| Toxicology | 3 | 301 | 189 | 373 | +2 |
| Immunology | 2 | 191 | 166 | 216 | - |
| Pathology | 1 | 718 | 718 | 718 | +1 |
| Total | 287 | 191 | 1 | 818 | +16 |
Key observations
Fastest reviews
The fastest individual clearance took 1 day. Reviews under 5 days typically reflect Special 510(k) submissions for minor modifications to already-cleared devices.
Longest review
The longest individual review reached 818 days. Extended reviews typically indicate additional information requests or complex predicate device questions. The FDA's standard target is 90 days from receipt.
Leading specialty: Orthopedic
Orthopedic led December 2022 with 45 clearances - 16% of all monthly clearances.
Review time spread
Pathology posted the highest average at 718 days. Neurology was fastest at 124 days. The gap of 594 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in December 2022 were Siemens Medical Solutions USA, Inc. (3) , Becton, Dickinson and Company (3) , Abbott Medical (2) , Ge Medical Systems Information Technologies, Inc. (2) and Boston Scientific Corporation (2) . Together, these five manufacturers accounted for 12 of the 287 total clearances - 4% of all December activity.
About this data
This report covers FDA 510(k) submissions with a decision date in December 2022 and a valid days-to-decision value. Data is sourced from the FDA 510(k) public files, published on the 5th of each month and 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.