# K945193: All-in-One Two Chamber Container

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: May 12, 1995 after 200 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020485: All-in-One Two Chamber Container 3200 ML, 2000 ML & 1000 ML (2002), 6 descendants of its own
- K041038: Churchill Medical Dual Chamber Empty Container (2004), 5 descendants of its own
- K121161: Empty Eva Solution Container Empty Eva Dual Chamber Solution Container (2012), 3 descendants of its own
- K193528: Empty EVA Bag (2020), 2 descendants of its own
- K210749: Empty EVA Bag (2021), 1 descendant of its own

Source page: https://510kreport.com/device/K945193
Methodology: https://510kreport.com/methodology