AmeriWater LLC.
Dayton, OH, US
AMERIWATER LLC. appears in FDA device records in Dayton, OH. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for AmeriWater LLC. between 2000 and 2023. The busiest year on record is 2014, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2003 | 2 |
| 2006 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 3 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF) | FIP | Substantially Equivalent | |
| K141213 | AMERIWATER OZONE DISINFECTION SYSTEM | FIN | Substantially Equivalent | |
| K142285 | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz | FIP | Substantially Equivalent | |
| K133783 | AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION | FIP | Substantially Equivalent | |
| K131904 | MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA | FIP | Substantially Equivalent | |
| K131622 | MROZ REVERSE OSMOSIS SYSTEM | FIP | Substantially Equivalent | |
| K121022 | AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV | FIP | Substantially Equivalent | |
| K111740 | AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION | FIP | Substantially Equivalent | |
| K051031 | AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS | FIN | Substantially Equivalent | |
| K021560 | MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS | FIP | Substantially Equivalent | |
| K030059 | PORTABLE RO+ MODEL MROS09 | FIP | Substantially Equivalent | |
| K991519 | AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS | FIP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1530185 | 1000515504 | AMERIWATER LLC. | 3345 Stop 8 Rd, DAYTON, OH 45414 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2321-2012 | 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 intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers. | 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. | Class II | Terminated | |
| Z-0004-05 | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain