FDA 510(k) Clearances - August 2024
280 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
August 2024 overview
The FDA cleared 280 medical devices in August 2024 through the 510(k) premarket notification pathway. This compares to 247 clearances in July 2024 - an increase of 33 (+13.4%).
Orthopedic led all specialties with 43 cleared devices. The fastest average review was Hematology at 28 days. The slowest was Microbiology at 322 days.
Overall average review time: 157 days, ranging from 1 to 1056 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - August 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 July |
|---|---|---|---|---|---|
| Orthopedic | 43 | 126 | 17 | 590 | +10 |
| General & Plastic Surgery | 41 | 133 | 23 | 1056 | - |
| Radiology | 40 | 134 | 23 | 338 | +9 |
| Cardiovascular | 24 | 151 | 17 | 300 | +1 |
| Dental | 22 | 198 | 1 | 703 | -4 |
| General Hospital | 21 | 116 | 26 | 270 | +6 |
| Neurology | 17 | 185 | 22 | 382 | +8 |
| Gastroenterology & Urology | 15 | 131 | 29 | 352 | -4 |
| Obstetrics & Gynecology | 10 | 178 | 25 | 424 | - |
| Anesthesiology | 10 | 230 | 57 | 408 | +3 |
| Physical Medicine | 10 | 176 | 62 | 311 | +3 |
| Microbiology | 9 | 322 | 90 | 884 | +3 |
| Chemistry | 8 | 203 | 32 | 760 | - |
| Ophthalmic | 6 | 248 | 30 | 613 | +1 |
| Toxicology | 2 | 35 | 29 | 40 | +1 |
| Hematology | 1 | 28 | 28 | 28 | - |
| Immunology | 1 | 171 | 171 | 171 | -1 |
| Total | 280 | 157 | 1 | 1056 | +33 |
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 1056 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 August 2024 with 43 clearances - 15% of all monthly clearances.
Review time spread
Microbiology posted the highest average at 322 days. Hematology was fastest at 28 days. The gap of 294 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in August 2024 were Fisher &Paykel Healthcare , Ltd. (3) , Biokit, S.A. (2) , Abbott Medical (2) , SurGenTec, LLC (2) and Siemens Medical Solutions USA, Inc. (2) . Together, these five manufacturers accounted for 11 of the 280 total clearances - 4% of all August activity.
About this data
This report covers FDA 510(k) submissions with a decision date in August 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.