# K993058: Pure Water Inc's Acidified Storage and Distribution System with Optional Remote Fill

- Pathway: 510(k) (Traditional)
- Applicant: Pure Water, Inc.
- Decided: Jan 24, 2000 after 133 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 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
- K120005: ACDS (2012), 0 descendants of its own

## Indications for use
The Pure Water, Inc. Acidified Storage and Distribution system with Remote Fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of hemodialysis patients.

Source page: https://510kreport.com/device/K993058
Methodology: https://510kreport.com/methodology