# K041884: Mueller Water Conditioning Water Purification System for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Mueller Water Conditioning, Inc.
- Decided: Feb 28, 2005 after 231 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: 1 generation back to K980182 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980182: Water Purification System for Hemodialysis, Usfilter/Ionpure, Inc. (1998) Summary page 1.

## Indications for use
Mueller Water Conditioning's Water Purification System for Hemodialysis is intended for use in hemodialysis treatment. The system is used to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate and to produce purified water for dialyzer reprocessing, equipment rinse and disinfection. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K041884
Methodology: https://510kreport.com/methodology