# K252094: eZSURE™ Empty Fluid Container

- Pathway: 510(k) (Special)
- Applicant: Epic Medical Pte., Ltd.
- Decided: Aug 1, 2025 after 29 days
- Product code: KPE (Container, I.V.)
- Device class: 2
- Regulation: 21 CFR 880.5025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K932477 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223674: eZSURE™ Empty Fluid Container (models 426030, 426040, 426110), Epic Medical Pte., Ltd. (2023) Summary page 5.
- K241442: eZSURE™ Empty Fluid Container with ProSeal™ Injection Site, Epic Medical Pte., Ltd. (2024) Summary page 5.

## Indications for use
The Empty Fluid Container is used to hold an admixture of compatible fluids for intravenous administration to a patient. Medication transfer in and out of the container is done using aseptic technique.

Source page: https://510kreport.com/device/K252094
Methodology: https://510kreport.com/methodology