# K051031: Ameriwater Solution Mix and Distribution System for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Ameriwater
- Decided: Jan 6, 2006 after 259 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: 2 generations back to K970674 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992793: Sodium Bicarbonate Mixing/Delivery System, and the Concentrate Delivery System, Better Water, Inc. (1999) Summary page 1.

## Indications for use
The AmeriWater Solution Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate and acid solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications AmeriWater Bicarb Mix and Distribution System, Models 00BC55-55, OOBC100-100, and OOBC100-200 (Dual Tanks): The AmeriWater Bicarb Mix and Distribution System for Hemodialysis is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications. AmeriWater Solution Mixing System, Model OOBC100 (Single Tank): The AmeriWater Solution Mixing System is intended to be used in a hemodialysis facility to mix and deliver, to the point(s) of use, bicarbonate and acid solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications. AmeriWater Acid Concentrate Distribution System, Models 00AS130, OOAS300, and OOAS500: The AmeriWater Acid Concentrate Distribution System is intended to be used in a hemodialysis facility to store and deliver, to the point(s) of use, acid concentrates necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications. AmeriWater Wallboxes for Dialysis: The AmeriWater Wallbox for Dialysis is intended to be used in a hemodialysis facility as the point of use connection for purified water, bicarbonate, and acid solutions necessary for hemodialysis. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

Source page: https://510kreport.com/device/K051031
Methodology: https://510kreport.com/methodology