Cleared Special

K241442 - eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (FDA 510(k) Clearance)

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

K241442 · Epic Medical Pte. , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
30d
Days
Class 2
Risk

K241442 is an FDA 510(k) clearance for the eZSURE™ Empty Fluid Container with ProSeal™ Injection Site. 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 June 21, 2024 after a review of 30 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 K241442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 128d · This submission: 30d
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 K241442.
Disposable Infusion Bag for Parenteral Nutrition
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KabiHelp® Uno
K251139 · Fresenius Kabi AG · Jan 2026
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 (models 426030, 426040, 426110)
K223674 · Epic Medical Pte. , Ltd. · Sep 2023