Data / Medical devices / United States / Ameriwater LLC.
Ameriwater LLC.: FDA-registered device maker in Dayton, OH, United States, 12 510(k) clearances
Ameriwater LLC. is registered with the FDA (registration 1530185) in Dayton, OH, United States. It lists 2 device types. The FDA files 12 510(k) clearances under its listings, the newest dated February 13, 2023. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1530185
- FEI number
- 1000515504
- Address
- 3345 Stop 8 Rd Suite A, Dayton, OH, United States, 45414
- Owner or operator
- AMERIWATER LLC (9009428)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 3, 1994
- Registered through
- 2026
- Brand names listed
- AMERIWATER SOLUTION MIX, AMERIWATER WATER P, AmeriWater Alarm Panel, AmeriWater Centurion Reverse Osmosis System, AmeriWater Heatsan, AmeriWater MRO Portable RO System, AmeriWater MROZ Reverse Osmosis System, AmeriWater MediQA Reverse Osmosis System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Subsystem, Water Purification | FIP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tank, Holding, Dialysis | FIN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 13, 2023 | K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF) | FIP | Substantially Equivalent | AmeriWater, LLC | accessdata.fda.gov |
| December 10, 2014 | K141213 | AMERIWATER OZONE DISINFECTION SYSTEM | FIN | Substantially Equivalent | Ameriwater | accessdata.fda.gov |
| December 1, 2014 | K142285 | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz | FIP | Substantially Equivalent | Ameriwater | accessdata.fda.gov |
| April 16, 2014 | K133783 | AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION | FIP | Substantially Equivalent | Ameriwater | accessdata.fda.gov |
| November 13, 2013 | K131904 | MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA | FIP | Substantially Equivalent | Ameriwater | accessdata.fda.gov |
| September 20, 2013 | K131622 | MROZ REVERSE OSMOSIS SYSTEM | FIP | Substantially Equivalent | Ameriwater | accessdata.fda.gov |
| September 17, 2012 | K121022 | AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV | FIP | Substantially Equivalent | Ameriwater | accessdata.fda.gov |
| October 5, 2011 | K111740 | AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION | FIP | Substantially Equivalent | Ameriwater | accessdata.fda.gov |
| January 6, 2006 | K051031 | AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS | FIN | Substantially Equivalent | Ameriwater | accessdata.fda.gov |
| August 14, 2003 | K021560 | MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS | FIP | Substantially Equivalent | Ameriwater | accessdata.fda.gov |
| April 14, 2000 | K991519 | AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS | FIP | Substantially Equivalent | Ameriwater | accessdata.fda.gov |
| August 24, 1995 | K924695 | ASEPTECH PORTABLE RO+ SYSTEM | FIP | Substantially Equivalent | Dayton Water Systems | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 9, 2012 | 62891 | Class II | Terminated | AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis ap | The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 250 volt 15 amp fuses, that was installed in the water system. The incorrect fuse may result in excessive heat in the fuse holder eventually resulting in failure of the device to operate. | accessdata.fda.gov |
| September 3, 2004 | 29925 | Not yet classified | Terminated | AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis. | The device has a potential risk of failure caused by faulty wiring within the electrical component. The wires can overheat and eventually break in two. | accessdata.fda.gov |
Compare with other makers
Updated February 13, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.