Cleared Special

K252094 - eZSURE™ Empty Fluid Container (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252094 · Epic Medical Pte. , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
29d
Days
Class 2
Risk

K252094 is an FDA 510(k) clearance for the eZSURE™ Empty Fluid Container. 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 August 1, 2025 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Epic Medical Pte. , Ltd. devices

Submission Details

510(k) Number K252094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 128d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K252094.
Disposable Infusion Bag for Parenteral Nutrition
K252079 · Beijing L&Z Medical Technology Development Co., Ltd. · Apr 2026
ClaveQS™ Bag
K251980 · Icu Medical, Inc. · Mar 2026
KabiHelp® Uno
K251139 · Fresenius Kabi AG · Jan 2026
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
eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)
K223674 · Epic Medical Pte. , Ltd. · Sep 2023