AmeriWater Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
12
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2321-2012Class IIAmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 August 9, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K223656AmeriWater MediQA Reverse Osmosis System (MSP3HF)February 13, 2023
K141213AMERIWATER OZONE DISINFECTION SYSTEMDecember 10, 2014
K142285AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater HeatsanDecember 1, 2014
K133783AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATIONApril 16, 2014
K131904MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSISNovember 13, 2013
K131622MROZ REVERSE OSMOSIS SYSTEMSeptember 20, 2013
K121022AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & September 17, 2012
K111740AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATIONOctober 5, 2011
K051031AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSISJanuary 6, 2006
K021560MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSISAugust 14, 2003
K030059PORTABLE RO+ MODEL MROS09April 7, 2003
K991519AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSISApril 14, 2000