# K030888: Eva Empty Solution Container

- Pathway: 510(k) (Special)
- Applicant: Metrix Co.
- Decided: Apr 2, 2003 after 12 days
- Product code: KPE (Container, I.V.)
- Device class: 2
- Regulation: 21 CFR 880.5025
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices 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.

## Most influential descendants
- K121161: Empty Eva Solution Container Empty Eva Dual Chamber Solution Container (2012), 3 descendants of its own
- K193528: Empty EVA Bag (2020), 2 descendants of its own
- K210749: Empty EVA Bag (2021), 1 descendant of its own
- K251139: KabiHelp® Uno; KabiHelp® Advance plus (2026), 0 descendants of its own
- K190328: HCT Empty EVA Container Pack (2019), 0 descendants of its own

## Recalls of this device
- Oct 9, 2024 · Class II · Z-0341-2025: A limited number of IV bags have been found to leak during filling.
- Oct 9, 2024 · Class II · Z-0344-2025: A limited number of IV bags have been found to leak during filling.
- Oct 9, 2024 · Class II · Z-0331-2025: A limited number of IV bags have been found to leak during filling.
- Oct 9, 2024 · Class II · Z-0332-2025: A limited number of IV bags have been found to leak during filling.
- Oct 9, 2024 · Class II · Z-0335-2025: A limited number of IV bags have been found to leak during filling.
- Oct 9, 2024 · Class II · Z-0337-2025: A limited number of IV bags have been found to leak during filling.
- Oct 9, 2024 · Class II · Z-0340-2025: A limited number of IV bags have been found to leak during filling.
- Oct 9, 2024 · Class II · Z-0342-2025: A limited number of IV bags have been found to leak during filling.
- Oct 9, 2024 · Class II · Z-0343-2025: A limited number of IV bags have been found to leak during filling.
- Oct 9, 2024 · Class II · Z-0333-2025: A limited number of IV bags have been found to leak during filling.
- Oct 9, 2024 · Class II · Z-0338-2025: A limited number of IV bags have been found to leak during filling.
- Oct 9, 2024 · Class II · Z-0345-2025: A limited number of IV bags have been found to leak during filling.
- Oct 9, 2024 · Class II · Z-0330-2025: A limited number of IV bags have been found to leak during filling.
- Oct 9, 2024 · Class II · Z-0334-2025: A limited number of IV bags have been found to leak during filling.
- Oct 9, 2024 · Class II · Z-0336-2025: A limited number of IV bags have been found to leak during filling.
- Oct 9, 2024 · Class II · Z-0339-2025: A limited number of IV bags have been found to leak during filling.
- Jun 23, 2016 · Class II · Z-2260-2016: An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of

## Indications for use
An empty container with sterile fluid path used to hold an admixture of compatible fluids for administration to a patient. Medication transfer is done using aseptic technique.

Source page: https://510kreport.com/device/K030888
Methodology: https://510kreport.com/methodology