FDA 510(k) Clearances - June 2023
301 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
June 2023 overview
The FDA cleared 301 medical devices in June 2023 through the 510(k) premarket notification pathway. This compares to 264 clearances in May 2023 - an increase of 37 (+14.0%).
Orthopedic led all specialties with 47 cleared devices. The fastest average review was Immunology at 27 days. The slowest was Anesthesiology at 383 days.
Overall average review time: 181 days, ranging from 1 to 1139 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - June 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 May |
|---|---|---|---|---|---|
| Orthopedic | 47 | 98 | 21 | 301 | +4 |
| General & Plastic Surgery | 45 | 219 | 28 | 1139 | +12 |
| Cardiovascular | 35 | 154 | 28 | 508 | +8 |
| General Hospital | 33 | 228 | 28 | 821 | +3 |
| Radiology | 30 | 159 | 24 | 638 | -5 |
| Dental | 21 | 201 | 1 | 399 | -4 |
| Anesthesiology | 16 | 383 | 175 | 696 | +7 |
| Neurology | 14 | 178 | 20 | 524 | +2 |
| Gastroenterology & Urology | 13 | 135 | 26 | 267 | -2 |
| Obstetrics & Gynecology | 8 | 161 | 21 | 314 | +3 |
| Ear, Nose, Throat | 7 | 183 | 105 | 273 | +2 |
| Chemistry | 7 | 173 | 29 | 569 | +2 |
| Microbiology | 7 | 110 | 27 | 325 | +2 |
| Ophthalmic | 6 | 153 | 24 | 276 | +1 |
| Physical Medicine | 6 | 94 | 28 | 267 | -1 |
| Hematology | 4 | 366 | 71 | 694 | +4 |
| Toxicology | 1 | 346 | 346 | 346 | - |
| Immunology | 1 | 27 | 27 | 27 | - |
| Total | 301 | 181 | 1 | 1139 | +37 |
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 1139 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 June 2023 with 47 clearances - 16% of all monthly clearances.
Review time spread
Anesthesiology posted the highest average at 383 days. Immunology was fastest at 27 days. The gap of 356 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in June 2023 were Boston Scientific Corporation (4) , STERIS Corporation (3) , Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2) , Edwards Lifesciences, LLC (2) and Nanjing Jusha Display Technology Co., Ltd. (2) . Together, these five manufacturers accounted for 13 of the 301 total clearances - 4% of all June activity.
About this data
This report covers FDA 510(k) submissions with a decision date in June 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.