Company ยท US
Ameriwater
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2023. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 13, 2023 | K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF) AmeriWater, LLC | FIP |
| Dec 10, 2014 | K141213 | AMERIWATER OZONE DISINFECTION SYSTEM Ameriwater | FIN |
| Dec 1, 2014 | K142285 | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60h Ameriwater | FIP |
| Apr 16, 2014 | K133783 | AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION Ameriwater | FIP |
| Nov 13, 2013 | K131904 | MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA Ameriwater | FIP |
| Sep 20, 2013 | K131622 | MROZ REVERSE OSMOSIS SYSTEM Ameriwater | FIP |
| Sep 17, 2012 | K121022 | AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV Ameriwater | FIP |
| Oct 5, 2011 | K111740 | AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION Ameriwater | FIP |
| Jan 6, 2006 | K051031 | AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS Ameriwater | FIN |
| Aug 14, 2003 | K021560 | MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS Ameriwater | FIP |
| Apr 7, 2003 | K030059 | PORTABLE RO+ MODEL MROS09 Ameriwater | FIP |
| Apr 14, 2000 | K991519 | AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS Ameriwater | FIP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2012 | AmeriWater Inc AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com.
The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems Terminated |
FIP | K111740 |
| Oct 5, 2004 | Ameriwater Inc AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis. Terminated |
FIP | K922695 |