FDA 510(k) Clearances - January 2024
209 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
January 2024 overview
The FDA cleared 209 medical devices in January 2024 through the 510(k) premarket notification pathway. This compares to 308 clearances in December 2023 - a decrease of 99 (-32.1%).
General & Plastic Surgery led all specialties with 36 cleared devices. The fastest average review was Ear, Nose, Throat at 123 days. The slowest was Anesthesiology at 403 days.
Overall average review time: 166 days, ranging from 27 to 762 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - January 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 December |
|---|---|---|---|---|---|
| General & Plastic Surgery | 36 | 172 | 32 | 629 | +3 |
| Orthopedic | 32 | 129 | 27 | 314 | -14 |
| Radiology | 30 | 148 | 28 | 454 | -19 |
| Dental | 17 | 197 | 59 | 570 | -8 |
| Gastroenterology & Urology | 16 | 186 | 28 | 449 | -1 |
| Neurology | 16 | 143 | 30 | 313 | -3 |
| Cardiovascular | 15 | 148 | 29 | 443 | -17 |
| General Hospital | 14 | 195 | 32 | 472 | -11 |
| Chemistry | 6 | 150 | 28 | 267 | -5 |
| Physical Medicine | 5 | 180 | 91 | 326 | -1 |
| Obstetrics & Gynecology | 5 | 136 | 58 | 220 | -4 |
| Ophthalmic | 4 | 162 | 28 | 421 | -3 |
| Anesthesiology | 4 | 403 | 247 | 762 | -4 |
| Toxicology | 3 | 134 | 132 | 135 | -1 |
| Ear, Nose, Throat | 3 | 123 | 50 | 193 | - |
| Microbiology | 2 | 268 | 263 | 272 | -7 |
| Immunology | 1 | 265 | 265 | 265 | - |
| Total | 209 | 166 | 27 | 762 | -99 |
Key observations
Fastest reviews
The fastest individual clearance took 27 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 762 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 January 2024 with 36 clearances - 17% of all monthly clearances.
Review time spread
Anesthesiology posted the highest average at 403 days. Ear, Nose, Throat was fastest at 123 days. The gap of 280 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in January 2024 were Shenzhen Ulike Smart Electronics Co., Ltd. (3) , Chengdu Besmile Medical Technology Co., Ltd. (2) , Stryker Endoscopy (2) , Lima Corporate S.P.A. (2) and Pentax of America, Inc. (2) . Together, these five manufacturers accounted for 11 of the 209 total clearances - 5% of all January activity.
About this data
This report covers FDA 510(k) submissions with a decision date in January 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.