# K030348: Biopure Portable RO System,Biopure 4400 Series RO System, Biopure 8400 Series RO System,Biopure Water Purfication Pretre

- Pathway: 510(k) (Traditional)
- Applicant: Biolab Equipment Canada, Ltd.
- Decided: Oct 21, 2003 after 260 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 K964539 (1997). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K980182: Water Purification System for Hemodialysis, Usfilter/Ionpure, Inc. (1998) Summary page 2.

## Most influential descendants
- K133149: Biopure HX2 Reverse Osmosis Water Purification System (2014), 0 descendants of its own
- K112331: Biopure Portable RO Systems (2012), 0 descendants of its own

## Indications for use
The device is intended to remove organic and inorganic substances arid microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate and to produce purified water for dialyzer reprocessing, and equipment rinse and disinfection.

Source page: https://510kreport.com/device/K030348
Methodology: https://510kreport.com/methodology