# K994279: Pure Water-CDS (Central Dialysis Solution)

- Pathway: 510(k) (Abbreviated)
- Applicant: Pure Water Solutions, Inc.
- Decided: Dec 22, 2000 after 368 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
This device is intended to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate, and to produce purified water for dialyzer reprocessing and equipment rinse and disinfection.

Source page: https://510kreport.com/device/K994279
Methodology: https://510kreport.com/methodology