# K193528: Empty EVA Bag

- Pathway: 510(k) (Traditional)
- Applicant: Haemotronic S.P.A.
- Decided: Jul 22, 2020 after 216 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 K945193 (1995). 8 ancestors in all.
2 later devices descend 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)
- K121161: Empty Eva Solution Container Empty Eva Dual Chamber Solution Container, Acta Medical, LLC (2012) Summary page 4.

## Most influential descendants
- K210749: Empty EVA Bag (2021), 1 descendant of its own
- 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 TPN (Total Parenteral Nutrition) solutions to the patient using an intravascular administration set. Medication transfer in and out of the container is done using aseptic technique.

Source page: https://510kreport.com/device/K193528
Methodology: https://510kreport.com/methodology