FDA 510(k) Clearances - November 2023
250 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
November 2023 overview
The FDA cleared 250 medical devices in November 2023 through the 510(k) premarket notification pathway. This compares to 309 clearances in October 2023 - a decrease of 59 (-19.1%).
Orthopedic led all specialties with 38 cleared devices. The fastest average review was Immunology at 88 days. The slowest was Anesthesiology at 255 days.
Overall average review time: 148 days, ranging from 1 to 537 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - November 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 October |
|---|---|---|---|---|---|
| Orthopedic | 38 | 108 | 21 | 527 | -17 |
| Radiology | 36 | 137 | 27 | 329 | -10 |
| General & Plastic Surgery | 36 | 126 | 23 | 336 | - |
| Cardiovascular | 26 | 150 | 28 | 440 | -2 |
| General Hospital | 20 | 170 | 57 | 421 | -11 |
| Dental | 19 | 146 | 1 | 433 | -4 |
| Gastroenterology & Urology | 19 | 185 | 57 | 461 | +2 |
| Neurology | 17 | 172 | 23 | 537 | -2 |
| Ophthalmic | 6 | 181 | 58 | 329 | +1 |
| Microbiology | 6 | 164 | 90 | 268 | -2 |
| Anesthesiology | 5 | 255 | 38 | 459 | -4 |
| Physical Medicine | 4 | 215 | 168 | 267 | -7 |
| Chemistry | 4 | 96 | 64 | 147 | -5 |
| Obstetrics & Gynecology | 4 | 183 | 30 | 254 | -2 |
| Ear, Nose, Throat | 4 | 161 | 136 | 190 | - |
| Hematology | 2 | 253 | 229 | 277 | +2 |
| Toxicology | 2 | 129 | 37 | 221 | - |
| Immunology | 2 | 88 | 86 | 90 | +2 |
| Total | 250 | 148 | 1 | 537 | -59 |
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 537 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 November 2023 with 38 clearances - 15% of all monthly clearances.
Review time spread
Anesthesiology posted the highest average at 255 days. Immunology was fastest at 88 days. The gap of 167 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in November 2023 were Siemens Medical Solutions USA, Inc. (4) , Aidoc Medical , Ltd. (3) , Boston Scientific (2) , Guilin Refine Medical Instrument Co., Ltd. (2) and Arthrex, Inc. (2) . Together, these five manufacturers accounted for 13 of the 250 total clearances - 5% of all November activity.
About this data
This report covers FDA 510(k) submissions with a decision date in November 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).
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