# K030059: Portable RO+ Model MROS09

- Pathway: 510(k) (Traditional)
- Applicant: Ameriwater
- Decided: Apr 7, 2003 after 90 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 K924695 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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 2.

## Most influential descendants
- K042089: NX Stage Water Purification System (2004), 0 descendants of its own

## Indications for use
The AmeriWater Portable RO+ Model MROSOS is a stand-alone water treatment system for use in hemodialysis applications. It is designed to pretreat and purify potable water for use in making dialysate for hemodialysis. The AmeriWater Portable RO+ with Onboard Pretreatment System is intended to be used in hospitals, clinics, home-care, and dialysis centers. It provides quiet operation for bedside use and may be used for acute care cases, small dialysis wings in hospitals, or to handle extra patients at dialysis centers.

Source page: https://510kreport.com/device/K030059
Methodology: https://510kreport.com/methodology