# K041038: Churchill Medical Dual Chamber Empty Container

- Pathway: 510(k) (Abbreviated)
- Applicant: Churchill Medical Systems, Inc.
- Decided: Dec 21, 2004 after 243 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: 2 generations back to K945193 (1995). 5 ancestors in all.
5 later devices descend from it; 2 cite 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)
- K960581: Secure Eva Dual Chamber Mixing Bag, Secure Medical Products, Inc. (1996) Summary page 1.
- K911567: Dual Compartment TPN Bag 3 Liter, Stedim, Inc. (1991) Summary page 1.
- K020485: All-in-One Two Chamber Container 3200 ML, 2000 ML & 1000 ML, Baxter Healthcare Corp (2002) Summary page 1.
- K972464: Vitalmix Plus Empty I.V. Container, Pacific Device, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K251139: KabiHelp® Uno; KabiHelp® Advance plus (2026), 0 descendants of its own
- K073538: Dual Chamber TPN Container (2008), 0 descendants of its own

## Indications for use
Churchill Medical Dual Chamber Empty Container is intended for the compounding, storage, and administration of total parenteral nutrition ( TPN solutions.

Source page: https://510kreport.com/device/K041038
Methodology: https://510kreport.com/methodology