# K992786: Pure Water, Inc.'S Water Purification Systems

- Pathway: 510(k) (Traditional)
- Applicant: Pure Water, Inc.
- Decided: Jan 24, 2000 after 158 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). 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)
- K920186: Water Purification System for Hemodialysis, Better Water, Inc. (1995) Summary page 1.
- K964539: Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF, F800-F802, RO Secura, Reverse Osmosis Syst, Zyzatech Water Systems, Inc. (1997) Summary page 1.

## Indications for use
The Pure Water, Inc. Water Purification System is intended to be used in Hemodialysis facilities for the purification of water to be used to dilute dialysate concentrate and in the reprocessing of dialyzers for reuse.

Source page: https://510kreport.com/device/K992786
Methodology: https://510kreport.com/methodology