# K222622: Disposable Infusion Bag for Parenteral Nutrition

- Pathway: 510(k) (Traditional)
- Applicant: Beijing L&Z Medical Technology Development Co., Ltd.
- Decided: Feb 16, 2023 after 169 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: 4 generations back to K932477 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101412: Eva TPN Bag, Valmed S.R.L. (2011) Summary page 5.

## Indications for use
The Disposable Infusion Bag for Parenteral Nutrition is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The device is not intended to store the fluids for 24 hours or greater.

Source page: https://510kreport.com/device/K222622
Methodology: https://510kreport.com/methodology