FDA 510(k) Applications for Medical Device Product Code "FIP"
(Subsystem, Water Purification)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K080703 | 4M VENTURES, INC. | BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK | 06/02/2008 |
| K001282 | AMERICAN INDUSTRIAL WATER | AIW WATER SYSTEM FOR HEMODIALYSIS | 12/15/2000 |
| K121022 | AMERIWATER | AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV | 09/17/2012 |
| K133783 | AMERIWATER | AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION | 04/16/2014 |
| K142285 | AmeriWater | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz | 12/01/2014 |
| K111740 | AMERIWATER | AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION | 10/05/2011 |
| K991519 | AMERIWATER | AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS | 04/14/2000 |
| K131904 | AMERIWATER | MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA | 11/13/2013 |
| K021560 | AMERIWATER | MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS | 08/14/2003 |
| K131622 | AMERIWATER | MROZ REVERSE OSMOSIS SYSTEM | 09/20/2013 |
| K030059 | AMERIWATER | PORTABLE RO+ MODEL MROS09 | 04/07/2003 |
| K223656 | AmeriWater, Llc | AmeriWater MediQA Reverse Osmosis System (MSP3HF) | 02/13/2023 |
| K102892 | AQUA SCIENCES, INC. | ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS | 02/03/2011 |
| K010592 | AQUA WATER TREATMENT, INC. | AQUA WATER TREATMENT FOR HEMODIALYSIS | 09/28/2001 |
| K112331 | ARION WATER, INC. | BIOPURE PORTABLE RO SYSTEMS | 07/05/2012 |
| K974127 | AUTOMATA INSTRUMENTATION, INC. | HYDRA METER | 12/19/1997 |
| K223479 | B. Braun Medical Inc. | AQUAbase nX | 08/16/2023 |
| K211035 | Baxter Healthcare Corporation | U9000 Plus Ultrafilter | 10/19/2021 |
| K051620 | BETTER WATER, INC. | MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES | 11/18/2005 |
| K954928 | BETTER WATER, INC. | PORTABLE REVERSE OSMOSIS MACHINE | 01/24/1996 |
| K161844 | BETTER WATER, LLC. | Matrix Pre-Treatment Controller | 12/13/2016 |
| K030348 | BIOLAB EQUIPMENT CANADA LTD. | BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE | 10/21/2003 |
| K014169 | BOB J. JOHNSON & ASSOC., INC | WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS | 02/06/2002 |
| K060942 | BOB J. JOHNSON & ASSOCIATES | WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS | 07/07/2006 |
| K171099 | Cantel | EON Portable Reverse Osmosis Water Purification System | 01/05/2018 |
| K993806 | CLARIGEN, INC. | DIALGUARD ENDOTOXIN REMOVAL DEVICE | 08/14/2000 |
| K082400 | CULLIGAN SOFT WATER SERVICE CO. | DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS | 02/03/2009 |
| K021352 | DAYTON WATER SYSTEMS | DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS | 08/01/2002 |
| K981680 | DAYTON WATER SYSTEMS | ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS | 12/31/1998 |
| K043344 | DIALYSIS SERVICES, INC. | DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM | 03/23/2005 |
| K083712 | DIPURE, LLC. | WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS | 07/10/2009 |
| K231410 | Evoqua Water Technologies LLC | RenaPure Endotoxin Retentive Filter | 07/19/2023 |
| K071104 | FLIER'S QUALITY WATER SYSTEMS INC | ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM | 01/14/2008 |
| K991495 | FLUID PROCESS SYSTEMS, INC. | FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS | 08/28/2000 |
| K182367 | Fresenius Medical Care Renal Therapies Group, LLC | DIASAFEplusUS | 01/10/2019 |
| K213507 | Fresenius Medical Care Rental Therapies Group, LLC | AquaA | 07/27/2022 |
| K944493 | G.E.M. WATER SYSTEMS | REVERSE OSMOSIS SYSTEM | 02/20/1996 |
| K974899 | GAMBRO HEALTHCARE | GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H | 09/23/1998 |
| K981085 | GAMBRO HEALTHCARE | GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM | 05/18/1998 |
| K003957 | GAMBRO RENAL PRODUCTS | DIACLEAR ULTRAFILTER | 11/01/2001 |
| K042797 | GAMBRO RENAL PRODUCTS | WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | 03/09/2005 |
| K093608 | GAMBRO RENAL PRODUCTS, INC. | GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H | 07/29/2010 |
| K061782 | GAMBRO SERVICES, INC. | GAMBRO POSICLEAR | 01/04/2007 |
| K022747 | HYDROPURE SYSTEMS, INC. | HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM | 02/11/2003 |
| K041163 | ISOPURE CORP. | ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES | 10/07/2004 |
| K993200 | ISOPURE CORP. | MD 420/440/460/470/480/490 | 01/24/2000 |
| K032004 | LAUER LTD., HONG KONG | AQUABOSS ECORO DIA 50 | 10/02/2003 |
| K124059 | LAUER MEMBRAN WASSERTECHNIK GMBH | AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) | 03/25/2013 |
| K133149 | MAR COR PURIFICATION, INC. | BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM | 04/30/2014 |
| K200670 | Mar Cor Purification, Inc. | EON Portable RO Water Purification System | 04/16/2020 |
| K192398 | Mar Cor Purification, Inc. | Millenium HX | 10/03/2019 |
| K110578 | MAR COR PURIFICATION, INC. | MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM | 05/20/2011 |
| K945559 | MAR COR SERVICES, INC. | MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS | 05/28/1996 |
| K003877 | MAR COR SERVICES, INC. | MAR COR SERVICES SEMPER PURE RO MACHINE | 06/22/2001 |
| K153329 | MED-TECH WATER SYSTEMS INC | MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis | 08/04/2016 |
| K031832 | MEGA SERVICES | MEGA PURE CART | 10/20/2004 |
| K983126 | MINNTECH CORP. | FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS | 03/08/1999 |
| K001755 | MPW INDUSTRIAL WATER SERVICES, INC. | MPW HEMODIALYSIS WATER PURIFICATION SYSTEM | 08/05/2002 |
| K041884 | MUELLER WATER CONDITIONING, INC. | MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | 02/28/2005 |
| K993877 | NELSON ENVIRONMENTAL TECHNOLOGIES, INC. | NELSON WATER SYSTEMS FOR HEMODIALYSIS | 05/25/2000 |
| K161304 | Nephros Inc. | EndoPur Filter | 03/02/2017 |
| K110285 | NEPHROS, INC. | NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER | 07/14/2011 |
| K090885 | NEPHROS, INC. | NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER | 06/29/2009 |
| K001811 | NEU-ION, INC. | NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM | 10/25/2000 |
| K092481 | NEW AQUA LLC (DBA AQUA SYSTEMS) | HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2 | 04/02/2010 |
| K042089 | NX STAGE MEDICAL INC | NX STAGE WATER PURIFICATION SYSTEM | 11/24/2004 |
| K033648 | PERFORMANCE WATER SYSTEMS, LLC | PERFORMANCE WATER TREATMENT SYSTEM | 08/09/2004 |
| K011005 | PURE WATER SOLUTIONS, INC. | PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS | 11/01/2002 |
| K994279 | PURE WATER SOLUTIONS, INC. | PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION) | 12/22/2000 |
| K992786 | PURE WATER, INC. | PURE WATER, INC.'S WATER PURIFICATION SYSTEMS | 01/24/2000 |
| K022448 | PURITY WATER COMPANY OF SAN ANTONIO, INC. | WATER PURIFICATION SYSTEM | 05/28/2003 |
| K983239 | RASCO | WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS | 11/18/1999 |
| K000249 | SCHAEFER WATER CENTERS | SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100 | 12/11/2000 |
| K993520 | SERV-A-PURE CO. | H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | 05/03/2000 |
| K042018 | SIMPLY CLEAN AIR & WATER, INC. | ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM | 04/15/2005 |
| K151637 | Specialty Water Technologies | UPT Series Medical RO Water System | 09/23/2015 |
| K072158 | STAUBACH BARROR WATER SYSTEMS, INC. | AQUA PURE DEIONIZER EXCHANGE SERVICE | 02/21/2008 |
| K002045 | TOTAL WATER TREATMENT SYSTEMS, INC. | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | 02/16/2001 |
| K030652 | U.S. FILTER/IONPURE, INC. | MEDRO SPD | 09/03/2003 |
| K013677 | U.S. FILTER/IONPURE, INC. | MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM | 03/08/2002 |
| K980182 | U.S. FILTER/IONPURE, INC. | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | 11/16/1998 |
| K123282 | ULTRAPURE & INDUSTRIAL SERVICES LLC | DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS | 04/25/2013 |
| K991916 | VIRGINIA WATER SYSTEMS, INC. | VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | 01/14/2000 |
| K133829 | VIVONIC GMBH | AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF | 04/22/2014 |
| K143617 | VIVONIC GMBH | AquaC UNO H | 10/19/2015 |
| K994292 | WATER & POWER TECHNOLOGIES, INC. | WATER PURIFICATION SYSTEM | 01/02/2001 |
| K983512 | WATER VAULT, INC. | WATER TREATMENT SYSTEM FOR HEMODIALYSIS | 04/28/1999 |
| K964539 | ZYZATECH WATER SYSTEMS, INC. | PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST | 11/26/1997 |
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