# K043344: Dialysis Services Water Treatment & Distribution System

- Pathway: 510(k) (Traditional)
- Applicant: Dialysis Services, Inc.
- Decided: Mar 23, 2005 after 107 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920186 (1995). 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)
- K920186: Water Purification System for Hemodialysis, Better Water, Inc. (1995) Summary page 3.

## Indications for use
The water treatment system and its components consisting of; pre- treatment, reverse osmosis machine, and tee product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments.

Source page: https://510kreport.com/device/K043344
Methodology: https://510kreport.com/methodology