K251715 is an FDA 510(k) clearance for the FlowArt® Vial Access Device Vented. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).
Submitted by Asset Medikal (Istanbul, TR). The FDA issued a Cleared decision on October 14, 2025, 132 days after receiving the submission on June 4, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K251715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2025 |
| Decision Date | October 14, 2025 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LHI - Set, I.v. Fluid Transfer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |