# K192398: Millenium HX

- Pathway: 510(k) (Special)
- Applicant: Mar Cor Purification, Inc.
- Decided: Oct 3, 2019 after 30 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: 4 generations back to K811678 (1981). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110578: Millenium HX Portable Reverse Osmosis Water Purification System, Mar Cor Purification, Inc. (2011) Summary page 4.
- K093608: Gambro Water Purification Unit, Models Wro 300 and Wro 300 H, Gambro Renal Products, Inc. (2010) Summary page 4.

## Indications for use
The Mar Cor Purification Millenium HX Portable Reverse Osmosis Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment. The Millenium HX can be connected to hemodialysis equipment used in hospitals, clinics and in home environments, in conjunction with the appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S) standards.

Source page: https://510kreport.com/device/K192398
Methodology: https://510kreport.com/methodology