FDA 510(k) Clearances - May 2023
264 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
May 2023 overview
The FDA cleared 264 medical devices in May 2023 through the 510(k) premarket notification pathway. This compares to 231 clearances in April 2023 - an increase of 33 (+14.3%).
Orthopedic led all specialties with 43 cleared devices. The fastest average review was Toxicology at 28 days. The slowest was Medical Genetics at 912 days.
Overall average review time: 191 days, ranging from 2 to 957 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - May 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 April |
|---|---|---|---|---|---|
| Orthopedic | 43 | 128 | 23 | 446 | +7 |
| Radiology | 35 | 176 | 16 | 626 | -2 |
| General & Plastic Surgery | 33 | 208 | 14 | 624 | -2 |
| General Hospital | 30 | 215 | 30 | 618 | +18 |
| Cardiovascular | 27 | 148 | 28 | 445 | -5 |
| Dental | 25 | 192 | 2 | 947 | +5 |
| Gastroenterology & Urology | 15 | 215 | 28 | 526 | +4 |
| Neurology | 12 | 161 | 27 | 298 | -2 |
| Anesthesiology | 9 | 344 | 155 | 782 | - |
| Physical Medicine | 7 | 263 | 29 | 957 | +3 |
| Chemistry | 5 | 136 | 27 | 415 | +1 |
| Obstetrics & Gynecology | 5 | 195 | 59 | 270 | +4 |
| Ophthalmic | 5 | 181 | 29 | 322 | - |
| Microbiology | 5 | 310 | 25 | 611 | -3 |
| Ear, Nose, Throat | 5 | 105 | 29 | 144 | +3 |
| Medical Genetics | 1 | 912 | 912 | 912 | +1 |
| Toxicology | 1 | 28 | 28 | 28 | +1 |
| Immunology | 1 | 898 | 898 | 898 | - |
| Total | 264 | 191 | 2 | 957 | +33 |
Key observations
Fastest reviews
The fastest individual clearance took 2 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 957 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 May 2023 with 43 clearances - 16% of all monthly clearances.
Review time spread
Medical Genetics posted the highest average at 912 days. Toxicology was fastest at 28 days. The gap of 884 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in May 2023 were Dentis Co., Ltd. (3) , Hologic, Inc. (3) , Nanjing Jusha Display Technology Co., Ltd. (2) , Shanghai United Imaging Healthcare Co., Ltd. (2) and Conformis, Inc. (2) . Together, these five manufacturers accounted for 12 of the 264 total clearances - 5% of all May activity.
About this data
This report covers FDA 510(k) submissions with a decision date in May 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.