Data / Medical devices / United States / Evoqua Water Technologies LLC
Evoqua Water Technologies LLC: FDA-registered device maker in Minneapolis, MN, United States, 26 510(k) clearances
Evoqua Water Technologies LLC is registered with the FDA (registration 3019131) in Minneapolis, MN, United States. It lists 6 device types. The FDA files 26 510(k) clearances under its listings, the newest dated July 19, 2023. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019131
- FEI number
- 3006475063
- Address
- 14550 28TH Avenue North, Minneapolis, MN, United States, 55447
- Owner or operator
- Evoqua Water Technologies, LLC (10057016)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- March 12, 2022
- Registered through
- 2026
- Brand names listed
- 23G Reverse Osmosis Equipment, 4400 & 8400 Portable RO systems, Bicarbonate Mixing Systems, CWP100 & WRO H Central Water Treatment System, Complete Water Treatment System for Hemodialysis, Dialysis Holding Tank, Dialysis Water Treatment & Distribution System, EON Portable RO Water Purification System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 2 | Manufacturer | accessdata.fda.gov |
| Dialyzer Reprocessing System | LIF | 2 | Manufacturer | accessdata.fda.gov |
| Disinfectant, Dialysate Delivery System | NII | 2 | Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Specification developer | accessdata.fda.gov |
| Subsystem, Water Purification | FIP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tank, Holding, Dialysis | FIN | 2 | 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 |
|---|---|---|---|---|---|---|
| July 19, 2023 | K231410 | RenaPure Endotoxin Retentive Filter | FIP | Substantially Equivalent | Evoqua Water Technologies, LLC | accessdata.fda.gov |
| April 16, 2020 | K200670 | EON Portable RO Water Purification System | FIP | Substantially Equivalent | Mar Cor Purification, Inc. | accessdata.fda.gov |
| October 3, 2019 | K192398 | Millenium HX | FIP | Substantially Equivalent | Mar Cor Purification, Inc. | accessdata.fda.gov |
| January 5, 2018 | K171099 | EON Portable Reverse Osmosis Water Purification System | FIP | Substantially Equivalent | Cantel | accessdata.fda.gov |
| April 30, 2014 | K133149 | BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM | FIP | Substantially Equivalent | Mar Cor Purification, Inc. | accessdata.fda.gov |
| May 20, 2011 | K110578 | MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM | FIP | Substantially Equivalent | Mar Cor Purification, Inc. | accessdata.fda.gov |
| July 29, 2010 | K093608 | GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H | FIP | Substantially Equivalent | Gambro Renal Products, Inc. | accessdata.fda.gov |
| January 4, 2007 | K061782 | GAMBRO POSICLEAR | FIP | Substantially Equivalent | Gambro Services, Inc. | accessdata.fda.gov |
| November 4, 2005 | K043207 | OZONE GENERATOR | NII | Substantially Equivalent | Ge Infrastructure Water & Process Technologies | accessdata.fda.gov |
| March 23, 2005 | K043344 | DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM | FIP | Substantially Equivalent | Dialysis Services, Inc. | accessdata.fda.gov |
| March 9, 2005 | K042797 | WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | FIP | Substantially Equivalent | Gambro Renal Products | accessdata.fda.gov |
| October 21, 2003 | K030348 | BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE | FIP | Substantially Equivalent | Biolab Equipment Canada , Ltd. | accessdata.fda.gov |
| June 26, 2003 | K023011 | OSMONICS SOLUTION DELIVERY SYSTEM | FIN | Substantially Equivalent | Osmonics Medical Systems | accessdata.fda.gov |
| May 28, 2003 | K022448 | WATER PURIFICATION SYSTEM | FIP | Substantially Equivalent | Purity Water Company of San Antonio, Inc. | accessdata.fda.gov |
| June 8, 2001 | K003560 | MAR COR SERVICES BICARB SYSTEM | FIN | Substantially Equivalent | Mar Cor Services, Inc. | accessdata.fda.gov |
| November 16, 1998 | K980182 | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | FIP | Substantially Equivalent | Usfilter/Ionpure, Inc. | accessdata.fda.gov |
| September 23, 1998 | K974899 | GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H | FIP | Substantially Equivalent | Gambro Healthcare | accessdata.fda.gov |
| May 18, 1998 | K981085 | GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM | FIP | Substantially Equivalent | Gambro Healthcare | accessdata.fda.gov |
| November 26, 1997 | K964539 | PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST | FIP | Substantially Equivalent | Zyzatech Water Systems, Inc. | accessdata.fda.gov |
| November 19, 1997 | K970674 | G.E.M. WATER SYSTEMS, INTERNATIONAL | FIN | Substantially Equivalent | G.E.M. Water Systems | accessdata.fda.gov |
| May 28, 1996 | K945559 | MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS | FIP | Substantially Equivalent | Mar Cor Services, Inc. | accessdata.fda.gov |
| February 20, 1996 | K944493 | REVERSE OSMOSIS SYSTEM | FIP | Substantially Equivalent | G.E.M. Water Systems | accessdata.fda.gov |
| June 26, 1995 | K941439 | RENALIN COLD STERILANT | LRJ | Substantially Equivalent | Minntech Corp. | accessdata.fda.gov |
| December 29, 1994 | K931595 | REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION | FIP | Substantially Equivalent | Osmonics, Inc. | accessdata.fda.gov |
| November 27, 1990 | K904210 | RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330 | LIF | Substantially Equivalent | Minntech Corp. | accessdata.fda.gov |
| March 31, 1983 | K830575 | RENALIN (TENTATIVE | LIF | Substantially Equivalent | Renal Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 24, 2014 | 68114 | Class II | Terminated | Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients. | Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106. This correction has been initiated due to a potential situation with a specific lot of the water inlet solenoid valve. The potential exists that the water inlet solenoid valve could cease to function. If this occurs, CWP will stop producing reverse os | accessdata.fda.gov |
| June 26, 2013 | 67517 | Class II | Terminated | Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use w | High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment. | accessdata.fda.gov |
| June 27, 2012 | 67516 | Class II | Terminated | Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106. | There exists a potential situation with the crimp connection at the pump head assembly. The potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive heating of the surrounding components. If this occurs, the pump head assembly may experience melting of the plastic components and potentially create smoke/fire an | accessdata.fda.gov |
Compare with other makers
- All makers of Subsystem, Water Purification
- All makers of Tank, Holding, Dialysis
- All makers of Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- All makers of Disinfectant, Dialysate Delivery System
- All makers of Disinfectant, Medical Devices
- All makers of Dialyzer Reprocessing System
Updated July 19, 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.