FDA 510(k) Clearances - January 2021
200 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
January 2021 overview
The FDA cleared 200 medical devices in January 2021 through the 510(k) premarket notification pathway. This compares to 276 clearances in December 2020 - a decrease of 76 (-27.5%).
Orthopedic led all specialties with 43 cleared devices. The fastest average review was Chemistry at 71 days. The slowest was Physical Medicine at 293 days.
Overall average review time: 172 days, ranging from 23 to 686 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - January 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 December |
|---|---|---|---|---|---|
| Orthopedic | 43 | 133 | 28 | 386 | -13 |
| General Hospital | 31 | 155 | 34 | 454 | -8 |
| Radiology | 24 | 133 | 26 | 493 | -5 |
| Cardiovascular | 22 | 188 | 23 | 418 | -9 |
| General & Plastic Surgery | 21 | 241 | 54 | 686 | -8 |
| Dental | 14 | 197 | 55 | 462 | -4 |
| Neurology | 11 | 132 | 28 | 217 | -5 |
| Anesthesiology | 9 | 207 | 77 | 401 | -4 |
| Gastroenterology & Urology | 8 | 209 | 28 | 366 | -8 |
| Obstetrics & Gynecology | 4 | 257 | 171 | 363 | -2 |
| Ear, Nose, Throat | 4 | 269 | 206 | 310 | +2 |
| Physical Medicine | 3 | 293 | 123 | 433 | -6 |
| Microbiology | 2 | 121 | 88 | 153 | -1 |
| Ophthalmic | 1 | 176 | 176 | 176 | -4 |
| Chemistry | 1 | 71 | 71 | 71 | - |
| Immunology | 1 | 192 | 192 | 192 | -1 |
| Toxicology | 1 | 113 | 113 | 113 | +1 |
| Total | 200 | 172 | 23 | 686 | -76 |
Key observations
Fastest reviews
The fastest individual clearance took 23 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 686 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 January 2021 with 43 clearances - 22% of all monthly clearances.
Review time spread
Physical Medicine posted the highest average at 293 days. Chemistry was fastest at 71 days. The gap of 222 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in January 2021 were Medacta International S.A. (4) , Siemens Medical Solutions USA, Inc. (3) , Edan Instruments, Inc. (3) , Argon Medical Devices, Inc. (2) and Roche Molecular Systems, Inc. (2) . Together, these five manufacturers accounted for 14 of the 200 total clearances - 7% of all January activity.
About this data
This report covers FDA 510(k) submissions with a decision date in January 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.