Cleared Special

eZSURE? Empty Fluid Container with ProSeal? Injection Site

K241442 · Epic Medical Pte. , Ltd. · General Hospital
Jun 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K241442 is an FDA 510(k) clearance for the eZSURE? Empty Fluid Container with ProSeal? Injection Site, 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 June 21, 2024, 30 days after receiving the submission on May 22, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5025.

Submission Details

510(k) Number K241442 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2024
Decision Date June 21, 2024
Days to Decision 30 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

Similar Devices — KPE Container, I.v.

All 114
KabiHelp? Uno; KabiHelp? Advance plus
K251139 · Fresenius Kabi AG · Jan 2026
eZSURE? Empty Fluid Container
K252094 · Epic Medical Pte. , Ltd. · Aug 2025
DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution
K250459 · Technoflex Sas. · Apr 2025
eZSURE? Empty Fluid Container (models 426030, 426040, 426110)
K223674 · Epic Medical Pte. , Ltd. · Sep 2023
Disposable Infusion Bag for Parenteral Nutrition
K222622 · Beijing L&Z Medical Technology Development Co., Ltd. · Feb 2023
Empty EVA Bag
K210749 · Haemotronic S.P.A. · Aug 2021