FDA 510(k) Clearances - May 2024
275 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
May 2024 overview
The FDA cleared 275 medical devices in May 2024 through the 510(k) premarket notification pathway. This compares to 246 clearances in April 2024 - an increase of 29 (+11.8%).
General & Plastic Surgery led all specialties with 44 cleared devices. The fastest average review was Toxicology at 41 days. The slowest was Anesthesiology at 314 days.
Overall average review time: 173 days, ranging from 7 to 872 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - May 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 April |
|---|---|---|---|---|---|
| General & Plastic Surgery | 44 | 147 | 27 | 329 | +11 |
| Orthopedic | 34 | 114 | 7 | 268 | -18 |
| Radiology | 33 | 182 | 23 | 340 | -1 |
| Dental | 28 | 188 | 29 | 564 | +8 |
| Cardiovascular | 26 | 143 | 28 | 540 | +3 |
| Gastroenterology & Urology | 17 | 152 | 27 | 270 | +4 |
| General Hospital | 16 | 186 | 17 | 322 | -4 |
| Obstetrics & Gynecology | 11 | 211 | 56 | 267 | +8 |
| Neurology | 10 | 251 | 29 | 679 | -1 |
| Microbiology | 10 | 220 | 23 | 872 | +3 |
| Anesthesiology | 10 | 314 | 106 | 649 | +7 |
| Chemistry | 8 | 173 | 25 | 269 | -1 |
| Ophthalmic | 7 | 261 | 28 | 781 | +3 |
| Immunology | 5 | 186 | 80 | 403 | +5 |
| Physical Medicine | 5 | 175 | 21 | 428 | +2 |
| Ear, Nose, Throat | 4 | 171 | 30 | 268 | -1 |
| Toxicology | 3 | 41 | 30 | 57 | +1 |
| Hematology | 2 | 151 | 57 | 244 | - |
| Pathology | 2 | 242 | 237 | 246 | - |
| Total | 275 | 173 | 7 | 872 | +29 |
Key observations
Fastest reviews
The fastest individual clearance took 7 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 872 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 & Plastic Surgery
General & Plastic Surgery led May 2024 with 44 clearances - 16% of all monthly clearances.
Review time spread
Anesthesiology posted the highest average at 314 days. Toxicology was fastest at 41 days. The gap of 273 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in May 2024 were Beckman Coulter, Inc. (3) , Mim Software, Inc. (3) , CenterPoint Systems, LLC (2) , Shanghai United Imaging Healthcare Co., Ltd. (2) and Merit Medical Systems, Inc. (2) . Together, these five manufacturers accounted for 12 of the 275 total clearances - 4% of all May activity.
About this data
This report covers FDA 510(k) submissions with a decision date in May 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.