eZSURE™ Empty Fluid Container - 426110
510(k) K223674
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223674 | Date1 Sep 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KPE
- FDA applicant
- Epic Medical Pte. , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5025
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The eZSURE Empty Fluid Container (models 426030, 426040, 426110) is an intravenous (I.V.) fluid container designed for use in hospital settings. Classified as a Container, I.V. (product code KPE), it is intended for holding and administering intravenous fluids in clinical environments.
These containers are supplied as single-use devices and are regulated under FDA 510(k) clearance (K223674) as substantially equivalent to predicate devices. They are intended for general hospital use and must comply with FDA regulation 880.5025. The devices are not reusable and are not specified for MRI compatibility or sterility beyond standard manufacturing practices for single-use medical devices.
Other devices from Epic Medical Pte., Ltd.
Questions
AI-generated answers, 19 Sep 2026
Are these empty fluid containers reusable or designed for single-use only?
The eZSURE Empty Fluid Container (models 426030, 426040, 426110) is explicitly designed for single-use only. The manufacturer’s description and FDA 510(k) submission confirm it is not intended for reuse, aligning with standard practices for intravenous fluid containers in hospital settings.
What sizes or models are available for the eZSURE Empty Fluid Container?
The eZSURE Empty Fluid Container comes in three models: 426030, 426040, and 426110. While the exact volumetric capacities or distinguishing features (e.g., port configurations) are not specified in the provided data, these models are classified under the same product code (KPE) for intravenous containers, indicating they are intended for general hospital use.
How should these containers be stored before use?
The eZSURE Empty Fluid Container is manufactured as a single-use device under standard sterility practices for medical devices. While specific storage instructions (e.g., temperature, humidity) aren’t detailed in the data, typical guidance for intravenous containers would recommend storing them in a clean, dry environment, protected from direct sunlight or extreme temperatures, until ready for use. Always follow the manufacturer’s accompanying instructions for optimal shelf life.
What is the regulatory pathway for this device, and how was it cleared?
The eZSURE Empty Fluid Container was cleared through the FDA 510(k) pathway under the classification Container, I.V. (product code KPE). The submission (K223674) was reviewed by the Hospital Devices Advisory Committee (HO) and determined to be substantially equivalent (SESE) to predicate devices, complying with FDA regulation 880.5025. This means it was evaluated for safety and effectiveness against existing, legally marketed devices in the same category.