# K994292: Water Purification System

- Pathway: 510(k) (Traditional)
- Applicant: Water & Power Technologies, Inc.
- Decided: Jan 2, 2001 after 378 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 K873487 (1987). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945559: Mar Cor Complete Water Treatment System for Kdney Dialysis, Mar Cor Services, Inc. (1996) Summary page 1.

## Most influential descendants
- K042089: NX Stage Water Purification System (2004), 0 descendants of its own

## Indications for use
The device is intended to remove organic and inorganic substances and-microbiai contaminants from water that is used to dilute dialysis concentrate to form dialysate and to produce purified water for dialyzer reprocessing and equipment srinse and disinfection.

Source page: https://510kreport.com/device/K994292
Methodology: https://510kreport.com/methodology