Cleared Traditional

EZ? IV Administration Set

K251814 · Epic Medical Pte. , Ltd. · General Hospital
Aug 2025
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K251814 is an FDA 510(k) clearance for the EZ? IV Administration Set, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on August 29, 2025, 77 days after receiving the submission on June 13, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K251814 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2025
Decision Date August 29, 2025
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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