# K092481: Hemodialysis Carbon Exchange, Dual Bed Deionizer Exchange, Mixed Bed Deionizer Exchange, Model .60MAW,1.2MAW,3.6MAW, 1.2

- Pathway: 510(k) (Traditional)
- Applicant: New Aqua, LLC (Dba Aqua Systems)
- Decided: Apr 2, 2010 after 232 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 Deionizer and Carbon Exchange Service for Hemodialysis are intended to be used in a hemodialysis facility according to AAMI standards to supply purified water for use in hemodialysis applications per the requirements of ANSI/AAMI RD62. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis. These exchange tanks are components of a larger water treatment system employing adequate pretreatment and post treatment sections. These tanks are not to be used alone. Upon exhaustion, these tanks will be replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether, or in the case of Carbon Tanks, with tanks containing fresh virgin carbon.

Source page: https://510kreport.com/device/K092481
Methodology: https://510kreport.com/methodology