# K251139: KabiHelp® Uno; KabiHelp® Advance plus

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Kabi AG
- Decided: Jan 9, 2026 after 270 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: 6 generations back to K945193 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210749: Empty EVA Bag, Haemotronic S.P.A. (2021) Summary page 5.

## Indications for use
The KabiHelp® Bag is an empty container to be filled with components of parenteral nutrition and parenteral nutrition related medication to be administered to the patients using an intravascular administration set. Parenteral nutrition and parenteral nutrition related medication transfer in and out of the container is done using aseptic technique.

Source page: https://510kreport.com/device/K251139
Methodology: https://510kreport.com/methodology