# K161844: Matrix Pre-Treatment Controller

- Pathway: 510(k) (Abbreviated)
- Applicant: Better Water, LLC
- Decided: Dec 13, 2016 after 161 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: 3 generations back to K944385 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 5.
- K051620: Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series, Better Water, Inc. (2005) Summary page 5.
- K041163: Isopure Complete Water System for Hemodialysis, MD 400 and MD 600 Series, Isopure, Corp. (2004) Summary page 5.

## Indications for use
Matrix Pre-Treatment Controller is designed to safely and effectively provide monitoring and control of the pre-treatment components for water purification for dialysis applications. These pre-treatment components include media-tanks with controllable valves (for example, but not limited to: multi-media depth filters, filox media filters, water softeners, dealkalizers, organic scavengers, and carbon media filters), city booster pump, ultra-violet light dump valve, blend-valve by-pass valve, and the main water shut-off valve. It monitors water pressures, water temperature, Delta-P pressures (change in pressure between two points), water flow-rate, water pH, empty bed contact time for carbon media filters, and the status of the media-tanks' valve cycles. This operational data is displayed on a HMI-touch screen along with trends, alarms, and events. It controls the regeneration and backwash cycles for media tanks, the city booster pump, the ultra-violet light dump valve for cooling purposes, the blend-valve by-pass valve to allow greater flow during backwash and regeneration, and the main water shut-off valve if a leak is detected. Although it is designed to work with Better Water LLC equipment, it can be used with non-Better Water equipment provided certain components are added or replaced to ensure compatibility.

Source page: https://510kreport.com/device/K161844
Methodology: https://510kreport.com/methodology