FDA 510(k) Clearances - July 2022
255 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
July 2022 overview
The FDA cleared 255 medical devices in July 2022 through the 510(k) premarket notification pathway. This compares to 279 clearances in June 2022 - a decrease of 24 (-8.6%).
Radiology led all specialties with 37 cleared devices. The fastest average review was Physical Medicine at 88 days. The slowest was Hematology at 767 days.
Overall average review time: 183 days, ranging from 1 to 767 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - July 2022
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 | 37 | 138 | 17 | 613 | -3 |
| General & Plastic Surgery | 36 | 175 | 23 | 651 | +1 |
| Orthopedic | 34 | 154 | 25 | 449 | -4 |
| General Hospital | 30 | 141 | 25 | 443 | -5 |
| Cardiovascular | 24 | 181 | 8 | 495 | -6 |
| Dental | 23 | 225 | 1 | 526 | +2 |
| Anesthesiology | 13 | 238 | 99 | 445 | +9 |
| Neurology | 12 | 262 | 88 | 620 | -7 |
| Gastroenterology & Urology | 11 | 232 | 25 | 451 | -8 |
| Microbiology | 9 | 259 | 67 | 582 | +2 |
| Ear, Nose, Throat | 9 | 110 | 20 | 217 | +2 |
| Physical Medicine | 6 | 88 | 28 | 136 | +1 |
| Immunology | 3 | 462 | 228 | 669 | +2 |
| Chemistry | 3 | 369 | 88 | 541 | -1 |
| Obstetrics & Gynecology | 3 | 92 | 58 | 133 | -3 |
| Hematology | 1 | 767 | 767 | 767 | - |
| Ophthalmic | 1 | 112 | 112 | 112 | -6 |
| Total | 255 | 183 | 1 | 767 | -24 |
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 767 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 2022 with 37 clearances - 15% of all monthly clearances.
Review time spread
Hematology posted the highest average at 767 days. Physical Medicine was fastest at 88 days. The gap of 679 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in July 2022 were Lg Electronics.Inc (3) , Siemens Medical Solutions USA, Inc. (3) , Becton, Dickinson and Company (3) , GE Medical Systems Ultrasound and Primary Care Diagnostics (3) and Biotronik, Inc. (3) . Together, these five manufacturers accounted for 15 of the 255 total clearances - 6% of all July activity.
About this data
This report covers FDA 510(k) submissions with a decision date in July 2022 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.