# K131622: Mroz Reverse Osmosis System

- Pathway: 510(k) (Traditional)
- Applicant: Ameriwater
- Decided: Sep 20, 2013 after 109 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: 3 generations back to K894300 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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 2.
- K111740: Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 Station, Ameriwater (2011) Summary page 1.

## Indications for use
The AmenWater MROZ Reverse Osmosis System is a water treatment device Intended for use In heniodlalysis applications, It Is intended to be used as a component In the AmenWater Water Purification System (K(991519), and Isintended to purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmenWater MROZ Isintended for use in water moms insa hospital, clinic, or dialysis center. The device is Intended to be a component ina complete water purification system, and Isnot a complete water treatment system. It must be proceeded by pme-treatment devices, and may need to be followed by past-treatment devices as well to meet current MAMI and Federal (U.S.) standards. Model MRO3Z is a 3 membrane system designed to supply 6,600 gallons per day (gpd) of product water. Model MR04Z ls a4 membrane system designed to supply 8,800 gpd! of product water. Model MR05Z Is a 5 membrane system designed to supply 11,000 gpd! of product water. Model MROBZ is686 membrane systemns designed to supply 13,200 gpd of product water. Model MRO7Z Is a 7 membrane system designed to supply 15,400 gpd! of product water. Model MRO8Z is n 8 membrane system designed to supply 17,600 gpd of product water. Each model is available in a 208V, 230V, or 460V variant and Includes a divert- to-drain feature to prevent patient exposure to unsafe product water. Each model Includes temperature compensated online monitors that display conductivity and percent rejection. The conductivity monitor activates an audible and visual alarm when the product water conductivity exceeds a preset alarm limit.

Source page: https://510kreport.com/device/K131622
Methodology: https://510kreport.com/methodology