# K983512: Water Treatment System for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Water Vault, Inc.
- Decided: Apr 28, 1999 after 203 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- 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 K873487 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945559: Mar Cor Complete Water Treatment System for Kdney Dialysis, Mar Cor Services, Inc. (1996) Summary page 1.

## Indications for use
The WaterVault Cube Water Treatment System for HemoDialysis is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate.

Source page: https://510kreport.com/device/K983512
Methodology: https://510kreport.com/methodology