FDA 510(k) Clearances - April 2023
231 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
April 2023 overview
The FDA cleared 231 medical devices in April 2023 through the 510(k) premarket notification pathway. This compares to 317 clearances in March 2023 - a decrease of 86 (-27.1%).
Radiology led all specialties with 37 cleared devices. The fastest average review was Radiology at 109 days. The slowest was Chemistry at 487 days.
Overall average review time: 180 days, ranging from 15 to 1211 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - April 2023
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 |
|---|---|---|---|---|---|
| Radiology | 37 | 109 | 23 | 479 | -5 |
| Orthopedic | 36 | 166 | 23 | 643 | -23 |
| General & Plastic Surgery | 35 | 117 | 25 | 376 | -10 |
| Cardiovascular | 32 | 178 | 28 | 516 | +6 |
| Dental | 20 | 202 | 57 | 686 | +3 |
| Neurology | 14 | 184 | 28 | 567 | -5 |
| General Hospital | 12 | 265 | 58 | 442 | -22 |
| Gastroenterology & Urology | 11 | 184 | 29 | 410 | -2 |
| Anesthesiology | 9 | 395 | 240 | 731 | -1 |
| Microbiology | 8 | 230 | 15 | 681 | -7 |
| Ophthalmic | 5 | 131 | 29 | 262 | - |
| Chemistry | 4 | 487 | 150 | 1211 | -1 |
| Physical Medicine | 4 | 250 | 49 | 581 | -5 |
| Ear, Nose, Throat | 2 | 166 | 135 | 197 | -2 |
| Obstetrics & Gynecology | 1 | 155 | 155 | 155 | -7 |
| Immunology | 1 | 393 | 393 | 393 | -1 |
| Total | 231 | 180 | 15 | 1211 | -86 |
Key observations
Fastest reviews
The fastest individual clearance took 15 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 1211 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: Radiology
Radiology led April 2023 with 37 clearances - 16% of all monthly clearances.
Review time spread
Chemistry posted the highest average at 487 days. Radiology was fastest at 109 days. The gap of 378 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in April 2023 were Medtronic, Inc. (4) , Philips Medical Systems Nederland B.V. (2) , Beckman Coulter, Inc. (2) , Arthrex, Inc. (2) and Brainlab AG (2) . Together, these five manufacturers accounted for 12 of the 231 total clearances - 5% of all April activity.
About this data
This report covers FDA 510(k) submissions with a decision date in April 2023 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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