# K112331: Biopure Portable RO Systems

- Pathway: 510(k) (Traditional)
- Applicant: Arion Water, Inc.
- Decided: Jul 5, 2012 after 328 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 K964539 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 2.
- K033648: Performance Water Treatment System, Performance Water Systems, LLC (2004) Summary page 3.

## Indications for use
The Anion Dialysis Water System is for use in multi-patient hemodialysis. The system consists of pretreatment, reverse osmosis, post-treatment and distribution equipment. The sizing of the system is consisting with the demand of water needed for patients. The water produced will meet the minimum requirements of ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications (RD52:2004 and R062:2006/A1 :2009) and the CMVS End Stage Renal Disease (ESRD) Program Interpretive Guidance (based on 42 CFR 494) when used as directed. RO and Pretreatment design is based off of feed water quality to meet the stated specifications. This system is intended to be used in hospitals, dialysis centers, and dialysis clinics.

Source page: https://510kreport.com/device/K112331
Methodology: https://510kreport.com/methodology