# K970674: G.E.M. Water Systems, International

- Pathway: 510(k) (Traditional)
- Applicant: G.E.M. Water Systems
- Decided: Nov 19, 1997 after 268 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K992793: Sodium Bicarbonate Mixing/Delivery System, and the Concentrate Delivery System (1999), 1 descendant of its own
- K051031: Ameriwater Solution Mix and Distribution System for Hemodialysis (2006), 0 descendants of its own
- K030366: Bicard Mixing System (2004), 0 descendants of its own
- K023011: Osmonics Solution Delivery System (2003), 0 descendants of its own

## Indications for use
THE INTENDED USE OF THESE DEVICES IS ALLOW THE HEMODIALYSIS FACILITY TO MIX SODIUM BICARBONATE POWDER WITH PRUIFIED WATER THAT MEETS AAMI| STANDARDS FOR HEMODIALYSIS TREATMENT, AND ALLOW THE MIXED SOLUTION TO BE AUTOMATICALLY DELIVERED TO THE DIALYSIS MACHINES.

Source page: https://510kreport.com/device/K970674
Methodology: https://510kreport.com/methodology