# K993272: Pure Water, Inc.'S Bicarb Mix, Storage and Distribution System

- Pathway: 510(k) (Traditional)
- Applicant: Pure Water, Inc.
- Decided: Apr 10, 2000 after 193 days
- Product code: FIN (Tank, Holding, Dialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920186 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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 1.
- K964539: Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-NF, F800-F802, RO Secura, Reverse Osmosis Syst, Zyzatech Water Systems, Inc. (1997) Summary page 1.

## Most influential descendants
- K112427: Bicarb Mixing and Distribution System (2012), 0 descendants of its own

## Recalls of this device
- May 19, 2011 · Not classified · Z-0033-2012: Software problem causes transfer line between mixing and storage tank to not be rinsed after disinfection, leaving residual chlorine in the line.

## Indications for use
The Pure Water, Inc.’s Bicarb Mix, Storage and Distribution system is intended to be used in Hemodialysis facilities for the mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.

Source page: https://510kreport.com/device/K993272
Methodology: https://510kreport.com/methodology