# K102892: Asi Deionizer & Carbon Exchange Service for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Aqua Sciences, Inc.
- Decided: Feb 3, 2011 after 126 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 ASI Deionizer and Carbon Exchange Tank Service for hemodialysis are intended to be used in a hemodialysis facility according to ANSIAAMI-RD62:2006 standards to supply purified water for use in hemodialysis. These exchange tanks are components of a larger water treatment system employing adequate pretreatment and post treatment sections. These exchange 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 qontaning virgin carbon. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.

Source page: https://510kreport.com/device/K102892
Methodology: https://510kreport.com/methodology