FDA 510(k) Clearances - December 2021
308 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
December 2021 overview
The FDA cleared 308 medical devices in December 2021 through the 510(k) premarket notification pathway. This compares to 255 clearances in November 2021 - an increase of 53 (+20.8%).
General Hospital led all specialties with 79 cleared devices. The fastest average review was Ear, Nose, Throat at 74 days. The slowest was Hematology at 518 days.
Overall average review time: 184 days, ranging from 1 to 775 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - December 2021
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 |
|---|---|---|---|---|---|
| General Hospital | 79 | 175 | 58 | 691 | +20 |
| Radiology | 40 | 140 | 20 | 488 | +4 |
| Orthopedic | 40 | 142 | 23 | 472 | +11 |
| General & Plastic Surgery | 38 | 216 | 35 | 485 | +13 |
| Dental | 22 | 164 | 1 | 371 | +7 |
| Neurology | 21 | 204 | 32 | 550 | +6 |
| Cardiovascular | 19 | 205 | 19 | 618 | -6 |
| Gastroenterology & Urology | 9 | 139 | 30 | 247 | -5 |
| Anesthesiology | 8 | 239 | 50 | 403 | +4 |
| Ophthalmic | 8 | 133 | 27 | 270 | +6 |
| Microbiology | 5 | 478 | 211 | 775 | - |
| Obstetrics & Gynecology | 4 | 117 | 45 | 177 | -5 |
| Toxicology | 4 | 315 | 183 | 380 | +4 |
| Physical Medicine | 4 | 250 | 98 | 457 | -5 |
| Chemistry | 3 | 420 | 150 | 745 | -1 |
| Ear, Nose, Throat | 2 | 74 | 20 | 128 | -1 |
| Hematology | 1 | 518 | 518 | 518 | +1 |
| Pathology | 1 | 151 | 151 | 151 | +1 |
| Total | 308 | 184 | 1 | 775 | +53 |
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 775 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 December 2021 with 79 clearances - 26% of all monthly clearances.
Review time spread
Hematology posted the highest average at 518 days. Ear, Nose, Throat was fastest at 74 days. The gap of 444 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in December 2021 were Vy Spine, LLC (3) , Micro-Tech (Nanjing) Co., Ltd. (3) , Siemens Medical Solutions USA, Inc. (2) , Asahi Intecc Co., Ltd. (2) and Becton, Dickinson and Company (2) . Together, these five manufacturers accounted for 12 of the 308 total clearances - 4% of all December activity.
About this data
This report covers FDA 510(k) submissions with a decision date in December 2021 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.