FDA 510(k) Clearances - July 2023
251 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
July 2023 overview
The FDA cleared 251 medical devices in July 2023 through the 510(k) premarket notification pathway. This compares to 301 clearances in June 2023 - a decrease of 50 (-16.6%).
Orthopedic led all specialties with 52 cleared devices. The fastest average review was Ophthalmic at 71 days. The slowest was Chemistry at 381 days.
Overall average review time: 176 days, ranging from 1 to 854 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - July 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 June |
|---|---|---|---|---|---|
| Orthopedic | 52 | 117 | 11 | 497 | +5 |
| Radiology | 38 | 161 | 21 | 314 | +8 |
| General Hospital | 25 | 202 | 20 | 819 | -8 |
| Cardiovascular | 24 | 157 | 27 | 451 | -11 |
| General & Plastic Surgery | 23 | 159 | 20 | 457 | -22 |
| Dental | 21 | 172 | 1 | 459 | - |
| Chemistry | 12 | 381 | 126 | 854 | +5 |
| Gastroenterology & Urology | 12 | 185 | 28 | 755 | -1 |
| Anesthesiology | 12 | 301 | 84 | 822 | -4 |
| Microbiology | 9 | 140 | 36 | 390 | +2 |
| Physical Medicine | 6 | 75 | 28 | 183 | - |
| Neurology | 5 | 207 | 63 | 322 | -9 |
| Obstetrics & Gynecology | 4 | 318 | 131 | 493 | -4 |
| Ophthalmic | 2 | 71 | 18 | 124 | -4 |
| Hematology | 2 | 279 | 29 | 528 | -2 |
| Ear, Nose, Throat | 2 | 182 | 28 | 336 | -5 |
| Toxicology | 2 | 234 | 49 | 418 | +1 |
| Total | 251 | 176 | 1 | 854 | -50 |
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 854 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 July 2023 with 52 clearances - 21% of all monthly clearances.
Review time spread
Chemistry posted the highest average at 381 days. Ophthalmic was fastest at 71 days. The gap of 310 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in July 2023 were STERIS Corporation (3) , Siemens Healthcare Diagnostics, Inc. (3) , L & K Biomed Co., Ltd. (3) , Conformis, Inc. (2) and Streck (2) . Together, these five manufacturers accounted for 13 of the 251 total clearances - 5% of all July activity.
About this data
This report covers FDA 510(k) submissions with a decision date in July 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.