# K083712: Water Purification Components for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Dipure, LLC
- Decided: Jul 10, 2009 after 207 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 K894300 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991519: Ameriwater Purification System for Hemodialysis, Ameriwater (2000) Summary page 1.

## Indications for use
The DiPure Deionization Tanks are exchangeable/rechargeable mix bed tanks intended to remove ions from the water to a sufficient level to allow safe treatment of Hemodialysis patients. These deionization tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or new resin altogether. The DiPure Carbon Exchange Tanks are activated carbon tanks intended to remove chlorine and chloramines from the water to allow safe treatment of Hemodialysis patients. These carbon tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks are replaced with other tanks containing new activated carbon.

Source page: https://510kreport.com/device/K083712
Methodology: https://510kreport.com/methodology