FDA 510(k) Clearances - April 2021
255 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
April 2021 overview
The FDA cleared 255 medical devices in April 2021 through the 510(k) premarket notification pathway. This compares to 272 clearances in March 2021 - a decrease of 17 (-6.2%).
Orthopedic led all specialties with 51 cleared devices. The fastest average review was Ophthalmic at 106 days. The slowest was Physical Medicine at 351 days.
Overall average review time: 149 days, ranging from 2 to 677 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - April 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 March |
|---|---|---|---|---|---|
| Orthopedic | 51 | 126 | 17 | 435 | +8 |
| Radiology | 38 | 121 | 14 | 437 | +1 |
| General Hospital | 35 | 176 | 30 | 407 | -33 |
| General & Plastic Surgery | 28 | 160 | 27 | 539 | +9 |
| Cardiovascular | 26 | 123 | 25 | 242 | +3 |
| Gastroenterology & Urology | 18 | 121 | 15 | 448 | +10 |
| Dental | 17 | 161 | 2 | 437 | -3 |
| Neurology | 11 | 234 | 21 | 677 | -7 |
| Ophthalmic | 9 | 106 | 29 | 244 | +6 |
| Anesthesiology | 7 | 185 | 113 | 287 | -3 |
| Obstetrics & Gynecology | 7 | 171 | 89 | 275 | +5 |
| Physical Medicine | 5 | 351 | 209 | 619 | -6 |
| Pathology | 1 | 150 | 150 | 150 | +1 |
| Chemistry | 1 | 256 | 256 | 256 | +1 |
| Toxicology | 1 | 144 | 144 | 144 | - |
| Total | 255 | 149 | 2 | 677 | -17 |
Key observations
Fastest reviews
The fastest individual clearance took 2 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 677 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 April 2021 with 51 clearances - 20% of all monthly clearances.
Review time spread
Physical Medicine posted the highest average at 351 days. Ophthalmic was fastest at 106 days. The gap of 245 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in April 2021 were Medacta International S.A. (5) , Boston Scientific Corporation (3) , Canon Medical Systems Corporation (3) , Medline Industries, Inc. (2) and Wide Corporation (2) . Together, these five manufacturers accounted for 15 of the 255 total clearances - 6% of all April activity.
About this data
This report covers FDA 510(k) submissions with a decision date in April 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).
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