FDA 510(k) Clearances - June 2022
279 medical devices cleared by the FDA. Data sourced from the FDA 510(k) public files.
June 2022 overview
The FDA cleared 279 medical devices in June 2022 through the 510(k) premarket notification pathway. This compares to 286 clearances in May 2022 - a decrease of 7 (-2.4%).
Radiology led all specialties with 40 cleared devices. The fastest average review was Microbiology at 80 days. The slowest was Hematology at 801 days.
Overall average review time: 188 days, ranging from 1 to 828 days. The FDA's standard 510(k) review target is 90 days.
Clearances by specialty - June 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 May |
|---|---|---|---|---|---|
| Radiology | 40 | 100 | 11 | 256 | -4 |
| Orthopedic | 38 | 208 | 25 | 756 | -9 |
| General & Plastic Surgery | 35 | 221 | 26 | 507 | +3 |
| General Hospital | 35 | 131 | 40 | 390 | -22 |
| Cardiovascular | 30 | 188 | 14 | 547 | +7 |
| Dental | 21 | 245 | 3 | 552 | +8 |
| Neurology | 19 | 174 | 29 | 448 | +3 |
| Gastroenterology & Urology | 19 | 167 | 30 | 353 | +6 |
| Microbiology | 7 | 80 | 1 | 169 | +2 |
| Ear, Nose, Throat | 7 | 194 | 125 | 270 | +6 |
| Ophthalmic | 7 | 200 | 59 | 298 | +3 |
| Obstetrics & Gynecology | 6 | 232 | 101 | 450 | -1 |
| Physical Medicine | 5 | 268 | 21 | 828 | -2 |
| Anesthesiology | 4 | 398 | 220 | 590 | -1 |
| Chemistry | 4 | 555 | 331 | 787 | -4 |
| Hematology | 1 | 801 | 801 | 801 | -1 |
| Immunology | 1 | 210 | 210 | 210 | +1 |
| Total | 279 | 188 | 1 | 828 | -7 |
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 828 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 June 2022 with 40 clearances - 14% of all monthly clearances.
Review time spread
Hematology posted the highest average at 801 days. Microbiology was fastest at 80 days. The gap of 721 days between fastest and slowest specialties reflects differences in device complexity and regulatory pathway.
Most active manufacturers
The most active manufacturers in June 2022 were Siemens Medical Solutions USA, Inc. (4) , Varian Medical Systems, Inc. (3) , Centers For Disease Control and Prevention (2) , Promisemed Hangzhou Meditech Co., Ltd. (2) and Stryker (2) . Together, these five manufacturers accounted for 13 of the 279 total clearances - 5% of all June activity.
About this data
This report covers FDA 510(k) submissions with a decision date in June 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).
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