# K121161: Empty Eva Solution Container Empty Eva Dual Chamber Solution Container

- Pathway: 510(k) (Traditional)
- Applicant: Acta Medical, LLC
- Decided: Jul 13, 2012 after 87 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: 3 generations back to K945193 (1995). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030888: Eva Empty Solution Container, Metrix Co. (2003) Summary page 1.
- K041038: Churchill Medical Dual Chamber Empty Container, Churchill Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K193528: Empty EVA Bag (2020), 2 descendants of its own
- K210749: Empty EVA Bag (2021), 1 descendant of its own
- K251139: KabiHelp® Uno; KabiHelp® Advance plus (2026), 0 descendants of its own

## Indications for use
An Empty Container with sterile fluid pathway used to store intravenous solution for administration to patient. Medication transfer in and out of the container is done using aseptic technique.

Source page: https://510kreport.com/device/K121161
Methodology: https://510kreport.com/methodology