# K042089: NX Stage Water Purification System

- Pathway: 510(k) (Traditional)
- Applicant: Nxstage Medical, Inc.
- Decided: Nov 24, 2004 after 113 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: 3 generations back to K873487 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030059: Portable RO+ Model MROS09, Ameriwater (2003) Summary page 1.
- K022747: Hydropure Portable Exchange Deionization (Pedi) System; Hydropure Back-UP Pedi System, Hydropure Systems, Inc. (2003) Summary page 1.
- K994292: Water Purification System, Water & Power Technologies, Inc. (2001) Summary page 1.
- K002045: Water Purification System for Hemodialysis, Total Water Treatment Systems, Inc. (2001) Summary page 1.

## Indications for use
The NxStage Water Purification System is a stand-alone water treatment system designed to pretreat and purify water for use in hemodialysis applications. The purified water can be used in preparation of dialysate, equipment rinsing and disinfection, and dialyzer reprocessing. It is intended to be used in a variety of environments, including acute or chronic care facility or home.

Source page: https://510kreport.com/device/K042089
Methodology: https://510kreport.com/methodology