FDA 510(k) Clearances - May 2021
194 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
May 2021 overview
The FDA cleared 194 medical devices in May 2021 through the 510(k) premarket notification pathway. This compares to 255 clearances in April 2021 - a decrease of 61 (-23.9%).
General Hospital led all specialties with 34 cleared devices. The fastest average review was Immunology at 29 days. The slowest was Chemistry at 389 days.
Overall average review time: 155 days, ranging from 14 to 796 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - May 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 April |
|---|---|---|---|---|---|
| General Hospital | 34 | 152 | 28 | 396 | -1 |
| Orthopedic | 33 | 137 | 21 | 445 | -18 |
| General & Plastic Surgery | 25 | 148 | 24 | 345 | -3 |
| Cardiovascular | 24 | 121 | 28 | 287 | -2 |
| Radiology | 20 | 111 | 14 | 435 | -18 |
| Gastroenterology & Urology | 13 | 117 | 29 | 223 | -5 |
| Physical Medicine | 11 | 198 | 14 | 780 | +6 |
| Dental | 11 | 219 | 54 | 436 | -6 |
| Obstetrics & Gynecology | 5 | 234 | 144 | 370 | -2 |
| Neurology | 5 | 319 | 25 | 796 | -6 |
| Ophthalmic | 4 | 164 | 53 | 241 | -5 |
| Anesthesiology | 3 | 211 | 131 | 293 | -4 |
| Ear, Nose, Throat | 2 | 152 | 30 | 273 | +2 |
| Chemistry | 2 | 389 | 280 | 497 | +1 |
| Microbiology | 1 | 266 | 266 | 266 | +1 |
| Immunology | 1 | 29 | 29 | 29 | +1 |
| Total | 194 | 155 | 14 | 796 | -61 |
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 796 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 May 2021 with 34 clearances - 18% of all monthly clearances.
Review time spread
Chemistry posted the highest average at 389 days. Immunology was fastest at 29 days. The gap of 360 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in May 2021 were Boston Scientific Corporation (3) , Medtronic, Inc. (2) , Medtronic Sofamor Danek USA, Inc. (2) , Nu Vasive, Incorporated (2) and Bausch & Lomb, Incorporated (2) . Together, these five manufacturers accounted for 11 of the 194 total clearances - 6% of all May activity.
About this data
This report covers FDA 510(k) submissions with a decision date in May 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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