FDA 510(k) Clearances - October 2024
293 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
October 2024 overview
The FDA cleared 293 medical devices in October 2024 through the 510(k) premarket notification pathway. This compares to 228 clearances in September 2024 - an increase of 65 (+28.5%).
Orthopedic led all specialties with 54 cleared devices. The fastest average review was Orthopedic at 101 days. The slowest was Pathology at 269 days.
Overall average review time: 146 days, ranging from 7 to 1212 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - October 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 September |
|---|---|---|---|---|---|
| Orthopedic | 54 | 101 | 18 | 612 | +17 |
| Radiology | 44 | 106 | 21 | 294 | +15 |
| General & Plastic Surgery | 44 | 200 | 7 | 1212 | +15 |
| Dental | 26 | 178 | 58 | 392 | +4 |
| General Hospital | 19 | 110 | 24 | 273 | -2 |
| Cardiovascular | 18 | 132 | 24 | 291 | -8 |
| Gastroenterology & Urology | 18 | 162 | 28 | 306 | +9 |
| Neurology | 14 | 182 | 29 | 396 | +1 |
| Physical Medicine | 12 | 152 | 57 | 239 | +2 |
| Anesthesiology | 10 | 178 | 29 | 289 | - |
| Microbiology | 10 | 127 | 28 | 414 | +5 |
| Ophthalmic | 8 | 136 | 57 | 271 | +6 |
| Chemistry | 4 | 230 | 209 | 255 | - |
| Obstetrics & Gynecology | 4 | 203 | 50 | 265 | -4 |
| Toxicology | 3 | 124 | 40 | 233 | +2 |
| Hematology | 2 | 255 | 251 | 259 | +2 |
| Ear, Nose, Throat | 2 | 206 | 146 | 265 | - |
| Pathology | 1 | 269 | 269 | 269 | +1 |
| Total | 293 | 146 | 7 | 1212 | +65 |
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 1212 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 October 2024 with 54 clearances - 18% of all monthly clearances.
Review time spread
Pathology posted the highest average at 269 days. Orthopedic was fastest at 101 days. The gap of 168 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in October 2024 were Philips Medical Systems Nederland B.V. (3) , Siemens Medical Solutions USA, Inc. (3) , Epic Medical Pte. , Ltd. (3) , Smith & Nephew, Inc. (3) and Arthrex, Inc. (2) . Together, these five manufacturers accounted for 14 of the 293 total clearances - 5% of all October activity.
About this data
This report covers FDA 510(k) submissions with a decision date in October 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.