FDA 510(k) Clearances - November 2021
255 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
November 2021 overview
The FDA cleared 255 medical devices in November 2021 through the 510(k) premarket notification pathway. This compares to 230 clearances in October 2021 - an increase of 25 (+10.9%).
General Hospital led all specialties with 59 cleared devices. The fastest average review was Radiology at 121 days. The slowest was Immunology at 381 days.
Overall average review time: 169 days, ranging from 14 to 834 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - November 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 October |
|---|---|---|---|---|---|
| General Hospital | 59 | 174 | 30 | 452 | +8 |
| Radiology | 36 | 121 | 14 | 352 | +12 |
| Orthopedic | 29 | 130 | 26 | 496 | +4 |
| Cardiovascular | 25 | 211 | 30 | 672 | +2 |
| General & Plastic Surgery | 25 | 125 | 51 | 464 | -7 |
| Neurology | 15 | 197 | 27 | 478 | +3 |
| Dental | 15 | 173 | 20 | 446 | -1 |
| Gastroenterology & Urology | 14 | 170 | 49 | 255 | +2 |
| Physical Medicine | 9 | 133 | 27 | 424 | +5 |
| Obstetrics & Gynecology | 9 | 197 | 79 | 454 | +2 |
| Microbiology | 5 | 365 | 203 | 834 | -2 |
| Chemistry | 4 | 238 | 131 | 384 | -1 |
| Anesthesiology | 4 | 322 | 202 | 566 | - |
| Ear, Nose, Throat | 3 | 169 | 133 | 219 | -1 |
| Ophthalmic | 2 | 196 | 147 | 245 | - |
| Immunology | 1 | 381 | 381 | 381 | -1 |
| Total | 255 | 169 | 14 | 834 | +25 |
Key observations
Fastest reviews
The fastest individual clearance took 14 days. Reviews under 5 days typically reflect Special 510(k) submissions for minor modifications to already-cleared devices.
Longest review
The longest individual review reached 834 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 2021 with 59 clearances - 23% of all monthly clearances.
Review time spread
Immunology posted the highest average at 381 days. Radiology was fastest at 121 days. The gap of 260 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in November 2021 were Arthrex, Inc. (2) , Stryker Neurovascular (2) , Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2) , Brainlab AG (2) and Nvision Biomedical Technologies, Inc. (2) . Together, these five manufacturers accounted for 10 of the 255 total clearances - 4% of all November activity.
About this data
This report covers FDA 510(k) submissions with a decision date in November 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.