Cleared Special

eZSURE? Empty Fluid Container

K252094 · Epic Medical Pte. , Ltd. · General Hospital
Aug 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K252094 is an FDA 510(k) clearance for the eZSURE? Empty Fluid Container, a Container, I.v. (Class II — Special Controls, product code KPE), submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on August 1, 2025, 29 days after receiving the submission on July 3, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5025.

Submission Details

510(k) Number K252094 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2025
Decision Date August 01, 2025
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KPE — Container, I.v.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5025

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