FDA 510(k) Clearances - July 2024
247 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
July 2024 overview
The FDA cleared 247 medical devices in July 2024 through the 510(k) premarket notification pathway. This compares to 260 clearances in June 2024 - a decrease of 13 (-5.0%).
General & Plastic Surgery led all specialties with 41 cleared devices. The fastest average review was Toxicology at 29 days. The slowest was Chemistry at 255 days.
Overall average review time: 143 days, ranging from 17 to 1073 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - July 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 June |
|---|---|---|---|---|---|
| General & Plastic Surgery | 41 | 154 | 25 | 1073 | +9 |
| Orthopedic | 33 | 102 | 17 | 450 | -11 |
| Radiology | 31 | 119 | 20 | 458 | +3 |
| Dental | 26 | 161 | 28 | 537 | +9 |
| Cardiovascular | 23 | 140 | 27 | 448 | -15 |
| Gastroenterology & Urology | 19 | 121 | 24 | 297 | +2 |
| General Hospital | 15 | 164 | 30 | 301 | -11 |
| Obstetrics & Gynecology | 10 | 137 | 29 | 258 | +1 |
| Neurology | 9 | 154 | 28 | 297 | -2 |
| Chemistry | 8 | 255 | 27 | 903 | +4 |
| Anesthesiology | 7 | 201 | 30 | 283 | -1 |
| Physical Medicine | 7 | 130 | 49 | 171 | - |
| Microbiology | 6 | 197 | 76 | 299 | -2 |
| Ophthalmic | 5 | 119 | 29 | 186 | +1 |
| Ear, Nose, Throat | 3 | 180 | 62 | 352 | +2 |
| Immunology | 2 | 84 | 83 | 84 | - |
| Toxicology | 1 | 29 | 29 | 29 | -1 |
| Hematology | 1 | 157 | 157 | 157 | +1 |
| Total | 247 | 143 | 17 | 1073 | -13 |
Key observations
Fastest reviews
The fastest individual clearance took 17 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 1073 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: General & Plastic Surgery
General & Plastic Surgery led July 2024 with 41 clearances - 17% of all monthly clearances.
Review time spread
Chemistry posted the highest average at 255 days. Toxicology was fastest at 29 days. The gap of 226 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in July 2024 were Beckman Coulter, Inc. (3) , Hologic, Inc. (3) , B.Braun Medical, Inc. (3) , Balt USA, LLC (2) and Boston Scientific Corporation (2) . Together, these five manufacturers accounted for 13 of the 247 total clearances - 5% of all July activity.
About this data
This report covers FDA 510(k) submissions with a decision date in July 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).
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