# K061197: Kawasumi Laboratories Empty Solution Container

- Pathway: 510(k) (Traditional)
- Applicant: Kawasumi Laboratories, Inc.
- Decided: Jun 30, 2006 after 63 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Abbott Laboratories Empty Container: named in the summary without a submission number

## Indications for use
The Kawasumi Laboratories Empty Solution Container is a sterile, single use device used as a reservoir for the purpose of administering solution to a patient. The Empty Solution Container is filled with the desired solution(s) commonly used in hospitals. After use, the bag is discarded.

Source page: https://510kreport.com/device/K061197
Methodology: https://510kreport.com/methodology