# K051620: Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series

- Pathway: 510(k) (Abbreviated)
- Applicant: Better Water, Inc.
- Decided: Nov 18, 2005 after 154 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 K944385 (1995). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 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 2.
- K993200: MD 420/440/460/470/480/490, Isopure, Corp. (2000) Summary page 2.
- K041163: Isopure Complete Water System for Hemodialysis, MD 400 and MD 600 Series, Isopure, Corp. (2004) Summary page 2.

## Most influential descendants
- K151637: UPT Series Medical RO Water System (2015), 1 descendant of its own
- K250514: UPT Series Medical RO Water Treatment System (2025), 0 descendants of its own
- K161844: Matrix Pre-Treatment Controller (2016), 0 descendants of its own

## Indications for use
The Matrix Series Digital Reverse Osmosis Water Treatment System is an accessory device designed to safely and effectively provide water purification for use in hemodialysis applications. The water produced will meet the minimum water quality requirements as specified by Association for the Advancement of Medical Instrumentation (AAMI) standard RD62:2003 when used as directed. Dependent on feed water quality this unit may be used in conjunction with other approved water treatment components.

Source page: https://510kreport.com/device/K051620
Methodology: https://510kreport.com/methodology