FDA 510(k) Clearances - October 2023
309 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
October 2023 overview
The FDA cleared 309 medical devices in October 2023 through the 510(k) premarket notification pathway. This compares to 309 clearances in September 2023 - a decrease of 0 (0.0%).
Orthopedic led all specialties with 55 cleared devices. The fastest average review was Orthopedic at 102 days. The slowest was Toxicology at 254 days.
Overall average review time: 153 days, ranging from 10 to 864 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - October 2023
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 | 55 | 102 | 13 | 509 | +3 |
| Radiology | 46 | 142 | 20 | 444 | +4 |
| General & Plastic Surgery | 36 | 187 | 26 | 864 | +7 |
| General Hospital | 31 | 180 | 14 | 760 | -1 |
| Cardiovascular | 28 | 119 | 20 | 282 | - |
| Dental | 23 | 205 | 59 | 537 | - |
| Neurology | 19 | 137 | 28 | 269 | +5 |
| Gastroenterology & Urology | 17 | 127 | 28 | 280 | -3 |
| Physical Medicine | 11 | 193 | 27 | 376 | - |
| Chemistry | 9 | 209 | 10 | 595 | -7 |
| Anesthesiology | 9 | 223 | 25 | 295 | +2 |
| Microbiology | 8 | 114 | 29 | 234 | +3 |
| Obstetrics & Gynecology | 6 | 126 | 66 | 229 | - |
| Ophthalmic | 5 | 182 | 96 | 329 | -1 |
| Ear, Nose, Throat | 4 | 213 | 149 | 292 | - |
| Toxicology | 2 | 254 | 16 | 492 | +2 |
| Total | 309 | 153 | 10 | 864 | - |
Key observations
Fastest reviews
The fastest individual clearance took 10 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 864 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 2023 with 55 clearances - 18% of all monthly clearances.
Review time spread
Toxicology posted the highest average at 254 days. Orthopedic was fastest at 102 days. The gap of 152 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in October 2023 were Siemens Medical Solutions USA, Inc. (3) , Steris (3) , Medline Industries, LP (3) , Vy Spine, LLC (3) and Alphatec Spine, Inc. (3) . Together, these five manufacturers accounted for 15 of the 309 total clearances - 5% of all October activity.
About this data
This report covers FDA 510(k) submissions with a decision date in October 2023 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.