# K920186: Water Purification System for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Better Water, Inc.
- Decided: Jun 13, 1995 after 1,246 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.
15 later devices descend from it; 9 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K051620: Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series (2005), 3 descendants of its own
- K151637: UPT Series Medical RO Water System (2015), 1 descendant of its own
- K033648: Performance Water Treatment System (2004), 1 descendant of its own
- K993272: Pure Water, Inc.'S Bicarb Mix, Storage and Distribution System (2000), 1 descendant of its own
- K993058: Pure Water Inc's Acidified Storage and Distribution System with Optional Remote Fill (2000), 1 descendant of its own

Source page: https://510kreport.com/device/K920186
Methodology: https://510kreport.com/methodology