FDA 510(k) Clearances - February 2024
214 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
February 2024 overview
The FDA cleared 214 medical devices in February 2024 through the 510(k) premarket notification pathway. This compares to 209 clearances in January 2024 - an increase of 5 (+2.4%).
Orthopedic led all specialties with 36 cleared devices. The fastest average review was Cardiovascular at 97 days. The slowest was Physical Medicine at 344 days.
Overall average review time: 151 days, ranging from 1 to 791 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - February 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 January |
|---|---|---|---|---|---|
| Orthopedic | 36 | 111 | 26 | 298 | +4 |
| Radiology | 32 | 133 | 24 | 265 | +2 |
| General & Plastic Surgery | 29 | 147 | 20 | 428 | -7 |
| Cardiovascular | 21 | 97 | 29 | 245 | +6 |
| Dental | 18 | 175 | 1 | 339 | +1 |
| General Hospital | 14 | 159 | 28 | 507 | - |
| Neurology | 14 | 161 | 29 | 341 | -2 |
| Gastroenterology & Urology | 10 | 156 | 28 | 250 | -6 |
| Chemistry | 7 | 162 | 59 | 266 | +1 |
| Anesthesiology | 6 | 257 | 59 | 371 | +2 |
| Physical Medicine | 5 | 344 | 56 | 791 | - |
| Ear, Nose, Throat | 5 | 134 | 28 | 302 | +2 |
| Ophthalmic | 4 | 139 | 50 | 228 | - |
| Obstetrics & Gynecology | 4 | 192 | 91 | 241 | -1 |
| Microbiology | 3 | 279 | 133 | 451 | +1 |
| Toxicology | 3 | 176 | 123 | 211 | - |
| Immunology | 2 | 239 | 210 | 267 | +1 |
| Pathology | 1 | 318 | 318 | 318 | +1 |
| Total | 214 | 151 | 1 | 791 | +5 |
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 791 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 February 2024 with 36 clearances - 17% of all monthly clearances.
Review time spread
Physical Medicine posted the highest average at 344 days. Cardiovascular was fastest at 97 days. The gap of 247 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in February 2024 were Beckman Coulter, Inc. (2) , Wontech Co., Ltd. (2) , Riverpoint Medical (2) , Stryker Endoscopy (2) and Depuy Ireland UC (1) . Together, these five manufacturers accounted for 9 of the 214 total clearances - 4% of all February activity.
About this data
This report covers FDA 510(k) submissions with a decision date in February 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.