# K973103: Chartermed TPN-Eva Bags

- Pathway: 510(k) (Traditional)
- Applicant: Chartermed, Inc.
- Decided: Nov 24, 1997 after 97 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: 1 generation back to K902079 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902079: Admixture Container for Total Parenteral Nutrition, Chartermed, Inc. (1990) Summary page 2.
- K911567: Dual Compartment TPN Bag 3 Liter, Stedim, Inc. (1991) Summary page 2.

## Indications for use
Empty bags made from ethyl vinyl acetate (EVA) film intended to contain total parenteral nutrition (TPN) solutions and compatible medications.

Source page: https://510kreport.com/device/K973103
Methodology: https://510kreport.com/methodology