# K072158: Aqua Pure Deionizer Exchange Service

- Pathway: 510(k) (Traditional)
- Applicant: Staubach Barror Water Systems, Inc.
- Decided: Feb 21, 2008 after 202 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: 2 generations back to K894300 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991519: Ameriwater Purification System for Hemodialysis, Ameriwater (2000) Summary page 1.

## Indications for use
The Aqua Pure DI exchange tanks are used according to current AAMI standards (RD 62) and are intended to supply dialysis grade water, for use in dialysis, concentrate preparation systems, dialyzer reuse systems and rinsing of sterilants. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis units. The D.I. exchange tanks for dialysis are only one part of a complete water treatment system and must be used in conjunction within a water treatment system with appropriate pre-treatment and post-treatment.

Source page: https://510kreport.com/device/K072158
Methodology: https://510kreport.com/methodology