FDA 510(k) Clearances - February 2021
228 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
February 2021 overview
The FDA cleared 228 medical devices in February 2021 through the 510(k) premarket notification pathway. This compares to 200 clearances in January 2021 - an increase of 28 (+14.0%).
Orthopedic led all specialties with 44 cleared devices. The fastest average review was Microbiology at 90 days. The slowest was Obstetrics & Gynecology at 337 days.
Overall average review time: 171 days, ranging from 8 to 1178 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - February 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 January |
|---|---|---|---|---|---|
| Orthopedic | 44 | 132 | 19 | 406 | +1 |
| General Hospital | 40 | 185 | 25 | 421 | +9 |
| Radiology | 37 | 150 | 14 | 350 | +13 |
| Dental | 24 | 256 | 29 | 1178 | +10 |
| General & Plastic Surgery | 23 | 143 | 52 | 364 | +2 |
| Cardiovascular | 19 | 165 | 22 | 408 | -3 |
| Neurology | 14 | 186 | 28 | 504 | +3 |
| Physical Medicine | 7 | 138 | 13 | 575 | +4 |
| Gastroenterology & Urology | 4 | 187 | 30 | 284 | -4 |
| Anesthesiology | 4 | 244 | 189 | 267 | -5 |
| Obstetrics & Gynecology | 4 | 337 | 218 | 444 | - |
| Microbiology | 4 | 90 | 8 | 167 | +2 |
| Ear, Nose, Throat | 3 | 152 | 58 | 214 | -1 |
| Ophthalmic | 1 | 188 | 188 | 188 | - |
| Total | 228 | 171 | 8 | 1178 | +28 |
Key observations
Fastest reviews
The fastest individual clearance took 8 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 1178 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 February 2021 with 44 clearances - 19% of all monthly clearances.
Review time spread
Obstetrics & Gynecology posted the highest average at 337 days. Microbiology was fastest at 90 days. The gap of 247 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in February 2021 were DiaSorin, Inc. (3) , Canon Medical Systems Corporation (2) , VATECH Co., Ltd. (2) , Stryker GmbH (2) and Philips Medical Systems Nederland B.V. (2) . Together, these five manufacturers accounted for 11 of the 228 total clearances - 5% of all February activity.
About this data
This report covers FDA 510(k) submissions with a decision date in February 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.