FDA 510(k) Clearances - March 2024
278 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
March 2024 overview
The FDA cleared 278 medical devices in March 2024 through the 510(k) premarket notification pathway. This compares to 214 clearances in February 2024 - an increase of 64 (+29.9%).
Orthopedic led all specialties with 48 cleared devices. The fastest average review was Immunology at 90 days. The slowest was Hematology at 235 days.
Overall average review time: 153 days, ranging from 1 to 1079 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - March 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 February |
|---|---|---|---|---|---|
| Orthopedic | 48 | 109 | 7 | 434 | +12 |
| Radiology | 34 | 141 | 20 | 271 | +2 |
| General & Plastic Surgery | 30 | 134 | 21 | 510 | +1 |
| General Hospital | 26 | 220 | 58 | 1079 | +12 |
| Dental | 25 | 157 | 1 | 423 | +7 |
| Cardiovascular | 22 | 137 | 15 | 269 | +1 |
| Neurology | 19 | 185 | 11 | 338 | +5 |
| Gastroenterology & Urology | 16 | 182 | 28 | 287 | +6 |
| Microbiology | 10 | 231 | 84 | 575 | +7 |
| Obstetrics & Gynecology | 9 | 212 | 89 | 309 | +5 |
| Chemistry | 8 | 128 | 35 | 266 | +1 |
| Physical Medicine | 6 | 123 | 49 | 265 | +1 |
| Anesthesiology | 6 | 163 | 51 | 305 | - |
| Ear, Nose, Throat | 6 | 98 | 30 | 137 | +1 |
| Toxicology | 4 | 108 | 30 | 254 | +1 |
| Immunology | 3 | 90 | 89 | 90 | +1 |
| Hematology | 3 | 235 | 82 | 358 | +3 |
| Ophthalmic | 3 | 195 | 150 | 266 | -1 |
| Total | 278 | 153 | 1 | 1079 | +64 |
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 1079 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 March 2024 with 48 clearances - 17% of all monthly clearances.
Review time spread
Hematology posted the highest average at 235 days. Immunology was fastest at 90 days. The gap of 145 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in March 2024 were Siemens Medical Solutions USA, Inc. (7) , Medtronic, Inc. (3) , Beckman Coulter, Inc. (3) , Prismatik Dentalcraft, Inc. (2) and Smith & Nephew, Inc. (2) . Together, these five manufacturers accounted for 17 of the 278 total clearances - 6% of all March activity.
About this data
This report covers FDA 510(k) submissions with a decision date in March 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.