# K210749: Empty EVA Bag

- Pathway: 510(k) (Traditional)
- Applicant: Haemotronic S.P.A.
- Decided: Aug 19, 2021 after 160 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: 5 generations back to K945193 (1995). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193528: Empty EVA Bag, Haemotronic S.P.A. (2020) Summary page 4.

## Most influential descendants
- K251139: KabiHelp® Uno; KabiHelp® Advance plus (2026), 0 descendants of its own

## Indications for use
The Empty EVA Bag is an empty container used for administration of solutions to the patients using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

Source page: https://510kreport.com/device/K210749
Methodology: https://510kreport.com/methodology