# K190328: HCT Empty EVA Container Pack

- Pathway: 510(k) (Traditional)
- Applicant: Health Care Technologies
- Decided: Aug 15, 2019 after 183 days
- Product code: KPE (Container, I.V.)
- Device class: 2
- Regulation: 21 CFR 880.5025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K030888 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030888: Eva Empty Solution Container, Metrix Co. (2003) Summary page 4.

## Recalls of this device
- Dec 15, 2022 · Class II · Z-0937-2023: Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
- Dec 15, 2022 · Class II · Z-0936-2023: Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

## 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/K190328
Methodology: https://510kreport.com/methodology