# K153329: MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis

- Pathway: 510(k) (Traditional)
- Applicant: Med-Tech Water Systems, Inc.
- Decided: Aug 4, 2016 after 259 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 K944493 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944493: Reverse Osmosis System, G.E.M. Water Systems (1996) Summary page 4.

## Indications for use
The MED-TECH Water Systems Inc. Exchangeable Carbon Tanks are intended to be used as a component of a hemodialysis water purification system designed to pretreat and purify potable water for hemodialysis applications. The exchange tanks are intended for use in complete water purification systems employing adequate pretreatment and post-treatment in accordance with current AAMI standards. The exchange tanks are not intended to be used alone. They are intended to remove chlorine and chloramines from water that will be purified by the water purification system and used for hemodialysis applications. Upon exhaustion, these tanks will be replaced with other tanks containing new activated carbon.

Source page: https://510kreport.com/device/K153329
Methodology: https://510kreport.com/methodology