FDA 510(k) Clearances - January 2022
235 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
January 2022 overview
The FDA cleared 235 medical devices in January 2022 through the 510(k) premarket notification pathway. This compares to 308 clearances in December 2021 - a decrease of 73 (-23.7%).
General Hospital led all specialties with 54 cleared devices. The fastest average review was Toxicology at 120 days. The slowest was Physical Medicine at 389 days.
Overall average review time: 184 days, ranging from 1 to 1002 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - January 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 December |
|---|---|---|---|---|---|
| General Hospital | 54 | 185 | 32 | 637 | -25 |
| Orthopedic | 42 | 138 | 19 | 484 | +2 |
| Radiology | 27 | 126 | 21 | 449 | -13 |
| Cardiovascular | 21 | 206 | 28 | 633 | +2 |
| General & Plastic Surgery | 20 | 189 | 26 | 479 | -18 |
| Dental | 20 | 217 | 1 | 617 | -2 |
| Gastroenterology & Urology | 11 | 149 | 60 | 262 | +2 |
| Physical Medicine | 8 | 389 | 100 | 1002 | +4 |
| Neurology | 8 | 211 | 23 | 438 | -13 |
| Ophthalmic | 5 | 157 | 25 | 267 | -3 |
| Anesthesiology | 5 | 236 | 133 | 290 | -3 |
| Chemistry | 5 | 362 | 158 | 451 | +2 |
| Ear, Nose, Throat | 3 | 127 | 90 | 149 | +1 |
| Obstetrics & Gynecology | 3 | 161 | 132 | 198 | -1 |
| Toxicology | 1 | 120 | 120 | 120 | -3 |
| Microbiology | 1 | 156 | 156 | 156 | -4 |
| Medical Genetics | 1 | 237 | 237 | 237 | +1 |
| Total | 235 | 184 | 1 | 1002 | -73 |
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 1002 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 January 2022 with 54 clearances - 23% of all monthly clearances.
Review time spread
Physical Medicine posted the highest average at 389 days. Toxicology was fastest at 120 days. The gap of 269 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in January 2022 were Insulet Corporation (3) , Varian Medical Systems, Inc. (2) , Medline Industries, Inc. (2) , Microport Orthopedics, Inc. (2) and Smith & Nephew Medical Limited (2) . Together, these five manufacturers accounted for 11 of the 235 total clearances - 5% of all January activity.
About this data
This report covers FDA 510(k) submissions with a decision date in January 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).
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