# K110578: Millenium HX Portable Reverse Osmosis Water Purification System

- Pathway: 510(k) (Traditional)
- Applicant: Mar Cor Purification, Inc.
- Decided: May 20, 2011 after 80 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K811678 (1981). 5 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093608: Gambro Water Purification Unit, Models Wro 300 and Wro 300 H, Gambro Renal Products, Inc. (2010) Summary page 2.
- K003877: Mar Cor Services Semper Pure RO Machine, Mar Cor Services, Inc. (2001) Summary page 2.
- 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 2.

## Most influential descendants
- K171099: EON Portable Reverse Osmosis Water Purification System (2018), 1 descendant of its own
- K143617: AquaC UNO H (2015), 1 descendant of its own
- K250471: AquaC UNO H (2025), 0 descendants of its own
- K200670: EON Portable RO Water Purification System (2020), 0 descendants of its own
- K192398: Millenium HX (2019), 0 descendants of its own

## Recalls of this device
- Jun 26, 2013 · Class II · Z-1213-2014: High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment.

## 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 AAML and Federal (U.S) standards.

Source page: https://510kreport.com/device/K110578
Methodology: https://510kreport.com/methodology