# K022448: Water Purification System

- Pathway: 510(k) (Traditional)
- Applicant: Purity Water Company of San Antonio, Inc.
- Decided: May 28, 2003 after 306 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Better Water, Inc. Water Purification System for Hemodialysis: named in the summary without a submission number

## Indications for use
Purify water for hemodialysis treatment in dialysis centers/facilities having multiple treatment stations. Purify water for hemodialysis treatment in hospital intensive care units, critical care units, pediatric intensive care units, and other acute care applications within a hospital setting.

Source page: https://510kreport.com/device/K022448
Methodology: https://510kreport.com/methodology