# K133149: Biopure HX2 Reverse Osmosis Water Purification System

- Pathway: 510(k) (Traditional)
- Applicant: Mar Cor Purification, Inc.
- Decided: Apr 30, 2014 after 195 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030348: Biopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series RO System,Biopure Water Purfication Pretre, Biolab Equipment Canada, Ltd. (2003) Summary page 3.
- K110578: Millenium HX Portable Reverse Osmosis Water Purification System, Mar Cor Purification, Inc. (2011) Summary page 3.

## Indications for use
The BioPure HX2 Reverse Osmosis water purification system is designed to purify pre-treated water using reverse osmosis for making dialysate for hemodialysis applications. The device is intended to be a component in a complete water purification system. It must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. BioPure HX2 is intended for use in water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat disinfection process. The BioPure HX2 is available two different double pass configurations that supply 5 gallons per minute (gpm) and 11 gpm. Version HX2P-05 is a double pass triple membrane RO that produces up to 5 gpm of product water. Version HX2P-11 is a double pass six membrane RO that produces up to 11 gpm of product water.

Source page: https://510kreport.com/device/K133149
Methodology: https://510kreport.com/methodology