# K073538: Dual Chamber TPN Container

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Mar 12, 2008 after 86 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 K932477 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041415: Eva TPN Container, B.Braun Medical, Inc. (2004) Summary page 1.
- K041038: Churchill Medical Dual Chamber Empty Container, Churchill Medical Systems, Inc. (2004) Summary page 1.

## Indications for use
The Dual Chamber TPN Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The Dual Chamber TPN Container can be filled either by gravity or in conjunction with automated compounding equipment.

Source page: https://510kreport.com/device/K073538
Methodology: https://510kreport.com/methodology