# K200670: EON Portable RO Water Purification System

- Pathway: 510(k) (Special)
- Applicant: Mar Cor Purification, Inc.
- Decided: Apr 16, 2020 after 34 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: 5 generations back to K811678 (1981). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171099: EON Portable Reverse Osmosis Water Purification System, Cantel (2018) Summary page 4.
- K093608: Gambro Water Purification Unit, Models Wro 300 and Wro 300 H, Gambro Renal Products, Inc. (2010) Summary page 4.

## Indications for use
The EON Portable Reverse Osmosis Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment. EON can be connected to hemodialysis equipment used in hospitals, clinics and in home environments, in conjunction with the appropriate pre and post treatment units, as part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards. EON has optional heat disinfection cycles intended to disinfect the reverse osmosis (RO) machine and product loop, and connection tubing to the hemodialysis machine. EON’s heat disinfection cycle to disinfect the connection tubing (heat forward cycle) is intended to be used only with hemodialysis machines which contain their own heat disinfection cycles and hence are able to tolerate high temperatures. EON is not intended to heat disinfect the hemodialysis machine.

Source page: https://510kreport.com/device/K200670
Methodology: https://510kreport.com/methodology