FDA 510(k) Clearances - November 2022
271 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
November 2022 overview
The FDA cleared 271 medical devices in November 2022 through the 510(k) premarket notification pathway. This compares to 295 clearances in October 2022 - a decrease of 24 (-8.1%).
General Hospital led all specialties with 44 cleared devices. The fastest average review was Toxicology at 65 days. The slowest was Immunology at 767 days.
Overall average review time: 190 days, ranging from 1 to 907 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - November 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 October |
|---|---|---|---|---|---|
| General Hospital | 44 | 227 | 5 | 904 | -2 |
| General & Plastic Surgery | 42 | 151 | 24 | 570 | +3 |
| Orthopedic | 40 | 168 | 30 | 592 | -12 |
| Radiology | 35 | 141 | 24 | 422 | +5 |
| Dental | 25 | 182 | 1 | 567 | - |
| Cardiovascular | 20 | 170 | 28 | 519 | -7 |
| Gastroenterology & Urology | 12 | 178 | 30 | 506 | +1 |
| Neurology | 12 | 204 | 28 | 505 | - |
| Ophthalmic | 9 | 176 | 37 | 432 | +3 |
| Anesthesiology | 6 | 259 | 29 | 680 | -2 |
| Obstetrics & Gynecology | 6 | 200 | 90 | 431 | - |
| Ear, Nose, Throat | 5 | 228 | 170 | 283 | +1 |
| Microbiology | 4 | 316 | 29 | 775 | -5 |
| Chemistry | 4 | 151 | 23 | 263 | - |
| Immunology | 2 | 767 | 626 | 907 | - |
| Hematology | 2 | 494 | 349 | 638 | - |
| Physical Medicine | 1 | 210 | 210 | 210 | -11 |
| Medical Genetics | 1 | 765 | 765 | 765 | +1 |
| Toxicology | 1 | 65 | 65 | 65 | +1 |
| Total | 271 | 190 | 1 | 907 | -24 |
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 907 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: General Hospital
General Hospital led November 2022 with 44 clearances - 16% of all monthly clearances.
Review time spread
Immunology posted the highest average at 767 days. Toxicology was fastest at 65 days. The gap of 702 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in November 2022 were Medtronic (2) , Covidien (2) , GE Medical Systems SCS (2) , Dentsply Sirona (2) and Alphatec Spine, Inc. (2) . Together, these five manufacturers accounted for 10 of the 271 total clearances - 4% of all November activity.
About this data
This report covers FDA 510(k) submissions with a decision date in November 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.