FDA 510(k) Clearances - September 2023
309 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
September 2023 overview
The FDA cleared 309 medical devices in September 2023 through the 510(k) premarket notification pathway. This compares to 309 clearances in August 2023 - a decrease of 0 (0.0%).
Orthopedic led all specialties with 52 cleared devices. The fastest average review was Cardiovascular at 122 days. The slowest was Hematology at 465 days.
Overall average review time: 188 days, ranging from 1 to 1278 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - September 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 August |
|---|---|---|---|---|---|
| Orthopedic | 52 | 127 | 25 | 338 | -7 |
| Radiology | 42 | 128 | 21 | 617 | +14 |
| General Hospital | 32 | 161 | 28 | 589 | -6 |
| General & Plastic Surgery | 29 | 149 | 24 | 682 | -1 |
| Cardiovascular | 28 | 122 | 7 | 353 | -5 |
| Dental | 23 | 147 | 1 | 609 | +4 |
| Gastroenterology & Urology | 20 | 153 | 27 | 323 | +1 |
| Chemistry | 16 | 361 | 57 | 636 | +8 |
| Neurology | 14 | 191 | 59 | 550 | -2 |
| Physical Medicine | 11 | 351 | 28 | 1278 | +5 |
| Immunology | 9 | 462 | 28 | 711 | +5 |
| Anesthesiology | 7 | 305 | 29 | 701 | -6 |
| Ophthalmic | 6 | 239 | 153 | 456 | +1 |
| Obstetrics & Gynecology | 6 | 204 | 101 | 261 | -3 |
| Microbiology | 5 | 418 | 130 | 759 | -2 |
| Ear, Nose, Throat | 4 | 317 | 26 | 532 | -2 |
| Hematology | 4 | 465 | 359 | 506 | -2 |
| Medical Genetics | 1 | 434 | 434 | 434 | +1 |
| Total | 309 | 188 | 1 | 1278 | - |
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 1278 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 2023 with 52 clearances - 17% of all monthly clearances.
Review time spread
Hematology posted the highest average at 465 days. Cardiovascular was fastest at 122 days. The gap of 343 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in September 2023 were Beckman Coulter, Inc. (4) , Alphatec Spine, Inc. (3) , Exactech, Inc. (3) , Canon Medical Systems Corporation (3) and Siemens Medical Solutions USA, Inc. (3) . Together, these five manufacturers accounted for 16 of the 309 total clearances - 5% of all September activity.
About this data
This report covers FDA 510(k) submissions with a decision date in September 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.