# K111740: Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 Station

- Pathway: 510(k) (Abbreviated)
- Applicant: Ameriwater
- Decided: Oct 5, 2011 after 106 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K894300 (1990). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924695: Aseptech Portable RO+ System, Dayton Water Systems (1995) Summary page 1.
- K991519: Ameriwater Purification System for Hemodialysis, Ameriwater (2000) Summary page 1.

## Most influential descendants
- K133783: Ameriwater Centurion 1500+ Reverse Osmosis System with Heat Sanitization (2014), 0 descendants of its own
- K131622: Mroz Reverse Osmosis System (2013), 0 descendants of its own

## Recalls of this device
- Aug 9, 2012 · Class II · Z-2321-2012: The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses, that was installed in the water system. The incorrect fuse

## Indications for use
The AmeniWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeniWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeniWater Portable MR01 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.

Source page: https://510kreport.com/device/K111740
Methodology: https://510kreport.com/methodology