K242255 is an FDA 510(k) clearance for the Qitexio® 4-Way Stopcock (QIT014). This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).
Submitted by Medex (Saint-Priest, FR). The FDA issued a Cleared decision on April 29, 2025, 272 days after receiving the submission on July 31, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K242255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2024 |
| Decision Date | April 29, 2025 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMG - Stopcock, I.v. Set |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |