AmeriWater Inc
FDA Regulatory Profile
AmeriWater Inc appears in FDA public data with 1 recall, 12 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2321-2012, Class II) was initiated on August 9, 2012. Its most recent 510(k) clearance was granted on February 13, 2023.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 12
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2321-2012 | Class II | AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 | August 9, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF) | February 13, 2023 |
| K141213 | AMERIWATER OZONE DISINFECTION SYSTEM | December 10, 2014 |
| K142285 | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan | December 1, 2014 |
| K133783 | AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION | April 16, 2014 |
| K131904 | MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS | November 13, 2013 |
| K131622 | MROZ REVERSE OSMOSIS SYSTEM | September 20, 2013 |
| K121022 | AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & | September 17, 2012 |
| K111740 | AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION | October 5, 2011 |
| K051031 | AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS | January 6, 2006 |
| K021560 | MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS | August 14, 2003 |
| K030059 | PORTABLE RO+ MODEL MROS09 | April 7, 2003 |
| K991519 | AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS | April 14, 2000 |