FDA 510(k) Clearances - June 2024
260 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
June 2024 overview
The FDA cleared 260 medical devices in June 2024 through the 510(k) premarket notification pathway. This compares to 275 clearances in May 2024 - a decrease of 15 (-5.5%).
Orthopedic led all specialties with 44 cleared devices. The fastest average review was Immunology at 52 days. The slowest was Microbiology at 355 days.
Overall average review time: 167 days, ranging from 14 to 746 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - June 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 May |
|---|---|---|---|---|---|
| Orthopedic | 44 | 122 | 23 | 469 | +10 |
| Cardiovascular | 38 | 183 | 25 | 427 | +12 |
| General & Plastic Surgery | 32 | 141 | 14 | 287 | -12 |
| Radiology | 28 | 150 | 16 | 268 | -5 |
| General Hospital | 26 | 189 | 27 | 462 | +10 |
| Gastroenterology & Urology | 17 | 196 | 58 | 271 | - |
| Dental | 17 | 168 | 32 | 427 | -11 |
| Neurology | 11 | 168 | 30 | 277 | +1 |
| Obstetrics & Gynecology | 9 | 198 | 30 | 270 | -2 |
| Microbiology | 8 | 355 | 90 | 746 | -2 |
| Anesthesiology | 8 | 158 | 22 | 274 | -2 |
| Physical Medicine | 7 | 160 | 63 | 277 | +2 |
| Ophthalmic | 4 | 197 | 57 | 268 | -3 |
| Chemistry | 4 | 146 | 28 | 266 | -4 |
| Immunology | 2 | 52 | 18 | 85 | -3 |
| Toxicology | 2 | 89 | 28 | 150 | -1 |
| Pathology | 2 | 270 | 270 | 270 | - |
| Ear, Nose, Throat | 1 | 178 | 178 | 178 | -3 |
| Total | 260 | 167 | 14 | 746 | -15 |
Key observations
Fastest reviews
The fastest individual clearance took 14 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 746 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 2024 with 44 clearances - 17% of all monthly clearances.
Review time spread
Microbiology posted the highest average at 355 days. Immunology was fastest at 52 days. The gap of 303 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in June 2024 were GE Medical Systems Ultrasound and Primary Care Diagnostics (4) , Globus Medical, Inc. (3) , Siemens Medical Solutions USA, Inc. (2) , Biosense Webster, Inc. (2) and Nakanishi, Inc. (2) . Together, these five manufacturers accounted for 13 of the 260 total clearances - 5% of all June activity.
About this data
This report covers FDA 510(k) submissions with a decision date in June 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.