FDA 510(k) Clearances - August 2022
255 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
August 2022 overview
The FDA cleared 255 medical devices in August 2022 through the 510(k) premarket notification pathway. This compares to 255 clearances in July 2022 - a decrease of 0 (0.0%).
General Hospital led all specialties with 42 cleared devices. The fastest average review was Toxicology at 63 days. The slowest was Physical Medicine at 364 days.
Overall average review time: 190 days, ranging from 1 to 1192 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - August 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 July |
|---|---|---|---|---|---|
| General Hospital | 42 | 282 | 3 | 1192 | +12 |
| Orthopedic | 39 | 146 | 22 | 530 | +5 |
| General & Plastic Surgery | 33 | 153 | 20 | 499 | -3 |
| Radiology | 32 | 128 | 23 | 437 | -5 |
| Cardiovascular | 25 | 134 | 25 | 557 | +1 |
| Dental | 21 | 188 | 1 | 520 | -2 |
| Gastroenterology & Urology | 12 | 176 | 30 | 711 | +1 |
| Neurology | 9 | 201 | 30 | 334 | -3 |
| Microbiology | 7 | 258 | 6 | 433 | -2 |
| Ophthalmic | 7 | 204 | 29 | 344 | +6 |
| Anesthesiology | 6 | 215 | 30 | 379 | -7 |
| Chemistry | 5 | 345 | 24 | 693 | +2 |
| Physical Medicine | 5 | 364 | 126 | 789 | -1 |
| Ear, Nose, Throat | 4 | 166 | 102 | 197 | -5 |
| Obstetrics & Gynecology | 2 | 124 | 90 | 158 | -1 |
| Immunology | 2 | 299 | 212 | 386 | -1 |
| Pathology | 2 | 292 | 207 | 377 | +2 |
| Hematology | 1 | 299 | 299 | 299 | - |
| Toxicology | 1 | 63 | 63 | 63 | +1 |
| Total | 255 | 190 | 1 | 1192 | - |
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 1192 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: General Hospital
General Hospital led August 2022 with 42 clearances - 16% of all monthly clearances.
Review time spread
Physical Medicine posted the highest average at 364 days. Toxicology was fastest at 63 days. The gap of 301 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in August 2022 were Radformation, Inc. (3) , Arthrex, Inc. (3) , Baxter Healthcare Corporation (2) , Insulet Corporation (2) and Fujifilm Corporation (2) . Together, these five manufacturers accounted for 12 of the 255 total clearances - 5% of all August activity.
About this data
This report covers FDA 510(k) submissions with a decision date in August 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.