# K992793: Sodium Bicarbonate Mixing/Delivery System, and the Concentrate Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Better Water, Inc.
- Decided: Nov 16, 1999 after 89 days
- Product code: FIN (Tank, Holding, Dialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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 K970674 (1997). 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)
- K970674: G.E.M. Water Systems, International, G.E.M. Water Systems (1997) Summary page 1.

## Most influential descendants
- K051031: Ameriwater Solution Mix and Distribution System for Hemodialysis (2006), 0 descendants of its own

## Indications for use
THE INTENDED USE OF THESE DEVICES IS TO ALLOW THE HEMODIALYSIS FACILITY TO MIX SODIUM BICARBONATE POWDER WITH PURIFIED WATER THAT MEETS AAMI STANDARDS FOR HEMODIALYSIS TREATMENT, AND ALLOW MIXED SOLUTION TO BE AUTOMATICALLY DELIVERED TO THE DIALYSIS MACHINES. IT IS ALSO INTENDED TO AUTOMATICALLY DELIVER A PRE-MIXED CONCENTRATE SOLUTION TQ,-THE DIALYSIS MACHINE.

Source page: https://510kreport.com/device/K992793
Methodology: https://510kreport.com/methodology