# K252079: Disposable Infusion Bag for Parenteral Nutrition

- Pathway: 510(k) (Traditional)
- Applicant: Beijing L&Z Medical Technology Development Co., Ltd.
- Decided: Apr 2, 2026 after 274 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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/K252079
Methodology: https://510kreport.com/methodology