# K223674: eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)

- Pathway: 510(k) (Traditional)
- Applicant: Epic Medical Pte., Ltd.
- Decided: Sep 1, 2023 after 268 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: 5 generations back to K932477 (1994). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181393: Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP, Valmed S.R.L. (2019) Summary page 4.

## Most influential descendants
- K241442: eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (2024), 1 descendant of its own
- K252094: eZSURE™ Empty Fluid Container (2025), 0 descendants of its own

## 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/K223674
Methodology: https://510kreport.com/methodology