510(k) Report

Devices descending from K991519

11 later devices reach Ameriwater Purification System for Hemodialysis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131622Mroz Reverse Osmosis SystemAmeriwater20130—
+1K123282Deonization Exchange Tanks, Carbon Exchange TanksUltrapure & Industrial Services, LLC20130—
+1K121022Ameriwater Alarm Panel - Base Model and Remote, Base Model & Remote with Conductivity…Ameriwater20120—
+1K111740Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 StationAmeriwater201121
+1K102892Asi Deionizer & Carbon Exchange Service for HemodialysisAqua Sciences, Inc.20110—
+1K092481Hemodialysis Carbon Exchange, Dual Bed Deionizer Exchange, Mixed Bed Deionizer Exchange…New Aqua, LLC (Dba Aqua Systems)20100—
+1K083712Water Purification Components for HemodialysisDipure, LLC20090—
+1K082400Deionizer and Carbon Exchange Service for HemodialysisCulligan Soft Water Service Co.20090—
+1K080703Bti Filtration Deionization Exchange Tank; Bti Filtration Carbon Exchange Tank4m Ventures, Inc.20080—
+1K072158Aqua Pure Deionizer Exchange ServiceStaubach Barror Water Systems, Inc.20080—
+2K133783Ameriwater Centurion 1500+ Reverse Osmosis System with Heat SanitizationAmeriwater20140—