Cleared Traditional

K223674 - eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223674 · Epic Medical Pte. , Ltd. · General Hospital
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Sep 2023
Decision
268d
Days
Class 2
Risk

K223674 is an FDA 510(k) clearance for the eZSURE™ Empty Fluid Container (models 426030, 426040, 426110). Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on September 1, 2023 after a review of 268 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Epic Medical Pte. , Ltd. devices

Submission Details

510(k) Number K223674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2022
Decision Date September 01, 2023
Days to Decision 268 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 128d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KPE Container, I.v.

All 116
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K223674.
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KabiHelp® Uno
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eZSURE™ Empty Fluid Container
K252094 · Epic Medical Pte. , Ltd. · Aug 2025
DMRX 100ml Empty Container Solution
K250459 · Technoflex Sas. · Apr 2025
eZSURE™ Empty Fluid Container with ProSeal™ Injection Site
K241442 · Epic Medical Pte. , Ltd. · Jun 2024