K231071 is an FDA 510(k) clearance for the Mix2Vial® Transfer Device. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by West Pharma Services Il, Ltd. (Ra'Anana Central, IL). The FDA issued a Cleared decision on January 19, 2024, 280 days after receiving the submission on April 14, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K231071 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2023 |
| Decision Date | January 19, 2024 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LHI - Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |