FDA 510(k) Clearances - July 2026
275 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
July 2026 overview
The FDA cleared 275 medical devices in July 2026 through the 510(k) premarket notification pathway. This compares to 306 clearances in June 2026 - a decrease of 31 (-10.1%).
Radiology led all specialties with 50 cleared devices. The fastest average review was Toxicology at 35 days. The slowest was Medical Genetics at 349 days.
Overall average review time: 127 days, ranging from 1 to 404 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - July 2026
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 |
|---|---|---|---|---|---|
| Radiology | 50 | 133 | 7 | 299 | +10 |
| Orthopedic | 47 | 107 | 18 | 314 | +2 |
| Cardiovascular | 32 | 127 | 28 | 395 | +1 |
| General & Plastic Surgery | 27 | 115 | 22 | 269 | -14 |
| Gastroenterology & Urology | 20 | 125 | 20 | 330 | +11 |
| Dental | 18 | 113 | 1 | 404 | -6 |
| Neurology | 15 | 183 | 26 | 399 | -10 |
| General Hospital | 12 | 123 | 27 | 242 | -8 |
| Microbiology | 9 | 106 | 28 | 192 | +2 |
| Physical Medicine | 8 | 134 | 70 | 359 | -6 |
| Anesthesiology | 8 | 152 | 57 | 304 | -5 |
| Obstetrics & Gynecology | 7 | 131 | 28 | 238 | -8 |
| Ear, Nose, Throat | 7 | 160 | 112 | 208 | -1 |
| Pathology | 4 | 216 | 115 | 387 | +4 |
| Ophthalmic | 4 | 122 | 36 | 220 | +1 |
| Chemistry | 3 | 49 | 28 | 88 | -5 |
| Immunology | 2 | 132 | 116 | 148 | - |
| Medical Genetics | 1 | 349 | 349 | 349 | +1 |
| Toxicology | 1 | 35 | 35 | 35 | +1 |
| Total | 275 | 127 | 1 | 404 | -31 |
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 404 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: Radiology
Radiology led July 2026 with 50 clearances - 18% of all monthly clearances.
Review time spread
Medical Genetics posted the highest average at 349 days. Toxicology was fastest at 35 days. The gap of 314 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in July 2026 were Boston Scientific Corporation (4) , CenterPoint Systems, LLC (2) , Neurocareai, Inc. (Dba Savelife.Ai) (2) , Philips Medical Systems Nederland B.V. (2) and Hartalega NGC Sdn. Bhd. (2) . Together, these five manufacturers accounted for 12 of the 275 total clearances - 4% of all July activity.
About this data
This report covers FDA 510(k) submissions with a decision date in July 2026 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.