FDA 510(k) Clearances - April 2024
246 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
April 2024 overview
The FDA cleared 246 medical devices in April 2024 through the 510(k) premarket notification pathway. This compares to 278 clearances in March 2024 - a decrease of 32 (-11.5%).
Orthopedic led all specialties with 52 cleared devices. The fastest average review was Toxicology at 33 days. The slowest was Microbiology at 670 days.
Overall average review time: 178 days, ranging from 1 to 1318 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - April 2024
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 | 52 | 126 | 18 | 458 | +4 |
| Radiology | 34 | 151 | 23 | 269 | - |
| General & Plastic Surgery | 33 | 158 | 21 | 574 | +3 |
| Cardiovascular | 23 | 154 | 52 | 270 | +1 |
| Dental | 20 | 221 | 1 | 657 | -5 |
| General Hospital | 20 | 187 | 21 | 577 | -6 |
| Gastroenterology & Urology | 13 | 136 | 28 | 262 | -3 |
| Neurology | 11 | 188 | 14 | 517 | -8 |
| Chemistry | 9 | 267 | 98 | 816 | +1 |
| Microbiology | 7 | 670 | 200 | 1318 | -3 |
| Ear, Nose, Throat | 5 | 151 | 76 | 256 | -1 |
| Ophthalmic | 4 | 86 | 29 | 156 | +1 |
| Anesthesiology | 3 | 276 | 236 | 300 | -3 |
| Physical Medicine | 3 | 211 | 114 | 275 | -3 |
| Obstetrics & Gynecology | 3 | 219 | 152 | 276 | -6 |
| Pathology | 2 | 266 | 265 | 266 | +2 |
| Toxicology | 2 | 33 | 31 | 34 | -2 |
| Hematology | 2 | 181 | 90 | 272 | -1 |
| Total | 246 | 178 | 1 | 1318 | -32 |
Key observations
Fastest reviews
The fastest individual clearance took 1 day. Reviews under 5 days typically reflect Special 510(k) submissions for minor modifications to already-cleared devices.
Longest review
The longest individual review reached 1318 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 2024 with 52 clearances - 21% of all monthly clearances.
Review time spread
Microbiology posted the highest average at 670 days. Toxicology was fastest at 33 days. The gap of 637 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in April 2024 were Shanghai United Imaging Healthcare Co., Ltd. (3) , Beckman Coulter, Inc. (2) , Healgen Scientific, LLC (2) , Varian Medical Systems, Inc. (2) and Microport Orthopedics, Inc. (2) . Together, these five manufacturers accounted for 11 of the 246 total clearances - 4% of all April activity.
About this data
This report covers FDA 510(k) submissions with a decision date in April 2024 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.