# K033648: Performance Water Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Performance Water Systems, LLC
- Decided: Aug 9, 2004 after 263 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.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K112331: Biopure Portable RO Systems (2012), 0 descendants of its own

## Indications for use
The water treatment system and its components consisting of; pre-treatment, reverse osmosis machine, and the 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. NOTE: Federal Law restricts this device to sale by or on the order of a physician for use as a water treatment device for hemodialysis.

Source page: https://510kreport.com/device/K033648
Methodology: https://510kreport.com/methodology