Cleared Traditional

FlowArt? Vial Access Device Vented

K251715 · Asset Medikal · General Hospital

Oct 2025

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K251715 is an FDA 510(k) clearance for the FlowArt? Vial Access Device Vented, 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 review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K251715 FDA.gov
FDA Decision	Cleared 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