FDA 510(k) Clearances - November 2024
258 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
November 2024 overview
The FDA cleared 258 medical devices in November 2024 through the 510(k) premarket notification pathway. This compares to 293 clearances in October 2024 - a decrease of 35 (-11.9%).
Orthopedic led all specialties with 54 cleared devices. The fastest average review was Toxicology at 53 days. The slowest was Chemistry at 511 days.
Overall average review time: 153 days, ranging from 2 to 1279 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - November 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 October |
|---|---|---|---|---|---|
| Orthopedic | 54 | 112 | 2 | 539 | - |
| General & Plastic Surgery | 38 | 135 | 25 | 551 | -6 |
| Radiology | 38 | 129 | 28 | 269 | -6 |
| Cardiovascular | 24 | 134 | 31 | 269 | +6 |
| Dental | 20 | 162 | 56 | 522 | -6 |
| Physical Medicine | 15 | 138 | 26 | 430 | +3 |
| Neurology | 13 | 143 | 29 | 269 | -1 |
| Gastroenterology & Urology | 12 | 131 | 26 | 264 | -6 |
| General Hospital | 12 | 147 | 29 | 264 | -7 |
| Anesthesiology | 10 | 496 | 142 | 1279 | - |
| Chemistry | 6 | 511 | 28 | 931 | +2 |
| Microbiology | 6 | 56 | 20 | 90 | -4 |
| Obstetrics & Gynecology | 4 | 171 | 57 | 266 | - |
| Toxicology | 2 | 53 | 52 | 54 | -1 |
| Ophthalmic | 2 | 168 | 80 | 256 | -6 |
| Ear, Nose, Throat | 1 | 131 | 131 | 131 | -1 |
| Hematology | 1 | 176 | 176 | 176 | -1 |
| Total | 258 | 153 | 2 | 1279 | -35 |
Key observations
Fastest reviews
The fastest individual clearance took 2 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 1279 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 November 2024 with 54 clearances - 21% of all monthly clearances.
Review time spread
Chemistry posted the highest average at 511 days. Toxicology was fastest at 53 days. The gap of 458 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in November 2024 were GM Dos Reis Industria e Comercio Ltda. (3) , Coloplast Corp. (3) , Hologic, Inc. (2) , Nova Biomedical Corporation (2) and Intuitive Surgical, Inc. (2) . Together, these five manufacturers accounted for 12 of the 258 total clearances - 5% of all November activity.
About this data
This report covers FDA 510(k) submissions with a decision date in November 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.