# K991519: Ameriwater Purification System for Hemodialysis

- Pathway: 510(k) (Traditional)
- Applicant: Ameriwater
- Decided: Apr 14, 2000 after 350 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 K894300 (1990). 1 ancestor in all.
11 later devices descend from it; 10 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894300: Submersible Reverse Osmosis Water Purification Sys, U.S. Filter/Continental Water Systems (1990) Summary page 1.

## Most influential descendants
- K111740: Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 Station (2011), 2 descendants of its own
- 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
- K123282: Deonization Exchange Tanks, Carbon Exchange Tanks (2013), 0 descendants of its own
- K121022: Ameriwater Alarm Panel - Base Model and Remote, Base Model & Remote with Conductivity, Base Model & Remote with Resistiv (2012), 0 descendants of its own

## Indications for use
The AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS is intended to be used in hemodialysis to remove organic and inorganic substances and microbial contaminants from water. Purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple use and/or to prepare and dilute solutions for reprocessing procedures in multiple-use dialyzers. AmeriWater does not recommend nor endorse any other use for water treated with AmeriWater systems. AmeriWater further does not endorse any specific hemodialysis or reprocessing procedures or equipment. NOTE* Federal Law restricts this device to sale by or on the order of a physician for use as a water treatment device for hemodialysis.

Source page: https://510kreport.com/device/K991519
Methodology: https://510kreport.com/methodology