# K964825: Freedom Traveller

- Pathway: 510(k) (Traditional)
- Applicant: Impact Case Technologies, Inc.
- Decided: May 19, 1997 after 168 days
- Product code: MLW (Warmer, Peritoneal Dialysate)
- Device class: 2
- Regulation: 21 CFR 876.5630
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
for kidney patients who are on continuous ambulatory peritoneal dialysis. To heat the dialysate to within one degree of 98.6 (body temperature) as a preferred alternative to heating the dialysate using a commercial heating pad or microwave oven. The solution is heated in it's original packaging. The solution (dialysate) can be heated when travelling - utilizing the car cigarette lighter adapter.

Source page: https://510kreport.com/device/K964825
Methodology: https://510kreport.com/methodology