FDA 510(k) Clearances - September 2024
228 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
September 2024 overview
The FDA cleared 228 medical devices in September 2024 through the 510(k) premarket notification pathway. This compares to 280 clearances in August 2024 - a decrease of 52 (-18.6%).
Orthopedic led all specialties with 37 cleared devices. The fastest average review was Toxicology at 32 days. The slowest was Chemistry at 632 days.
Overall average review time: 176 days, ranging from 7 to 1281 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - September 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 August |
|---|---|---|---|---|---|
| Orthopedic | 37 | 124 | 16 | 350 | -6 |
| Radiology | 29 | 157 | 27 | 282 | -11 |
| General & Plastic Surgery | 29 | 131 | 28 | 345 | -12 |
| Cardiovascular | 26 | 172 | 7 | 435 | +2 |
| Dental | 22 | 260 | 84 | 856 | - |
| General Hospital | 21 | 202 | 23 | 505 | - |
| Neurology | 13 | 142 | 28 | 362 | -4 |
| Anesthesiology | 10 | 202 | 70 | 457 | - |
| Physical Medicine | 10 | 157 | 52 | 366 | - |
| Gastroenterology & Urology | 9 | 203 | 88 | 381 | -6 |
| Obstetrics & Gynecology | 8 | 144 | 57 | 234 | -2 |
| Microbiology | 5 | 193 | 109 | 266 | -4 |
| Chemistry | 4 | 632 | 126 | 1281 | -4 |
| Ear, Nose, Throat | 2 | 169 | 70 | 268 | +2 |
| Ophthalmic | 2 | 199 | 128 | 269 | -4 |
| Toxicology | 1 | 32 | 32 | 32 | -1 |
| Total | 228 | 176 | 7 | 1281 | -52 |
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 1281 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 September 2024 with 37 clearances - 16% of all monthly clearances.
Review time spread
Chemistry posted the highest average at 632 days. Toxicology was fastest at 32 days. The gap of 600 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in September 2024 were Medline Industries, LP (2) , Penumbra, Inc. (2) , Intuitive Surgical, Inc. (2) , Surgical Instrument Service and Savings, Inc. (2) and O&M Halyard, Inc. (2) . Together, these five manufacturers accounted for 10 of the 228 total clearances - 4% of all September activity.
About this data
This report covers FDA 510(k) submissions with a decision date in September 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.