FDA Product Code
FDA Product Code FIP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5665
510(k) Clearances — 117 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250471 | AquaC UNO H | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-14 | Traditional | PDF ↗ |
| K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-10-09 | Traditional | PDF ↗ |
| K252181 | AquaA | Fresenius Medical Care North America | 2025-09-09 | Traditional | PDF ↗ |
| K250514 | UPT Series Medical RO Water Treatment System | Specialty Water Technologies, Inc. | 2025-03-17 | Special | PDF ↗ |
| K232953 | AquaBplus; AquaB LITE | Fresenius Medical Care Renal Therapies Group, LLC | 2024-06-13 | Traditional | PDF ↗ |
| K223479 | AQUAbase nX | B.Braun Medical, Inc. | 2023-08-16 | Traditional | PDF ↗ |
| K231410 | RenaPure Endotoxin Retentive Filter | Evoqua Water Technologies, LLC | 2023-07-19 | Traditional | PDF ↗ |
| K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF) | AmeriWater, LLC | 2023-02-13 | Special | PDF ↗ |
| K213507 | AquaA | Fresenius Medical Care Rental Therapies Group, LLC | 2022-07-27 | Traditional | PDF ↗ |
| K211035 | U9000 Plus Ultrafilter | Baxter Healthcare Corporation | 2021-10-19 | Traditional | PDF ↗ |
| K200670 | EON Portable RO Water Purification System | Mar Cor Purification, Inc. | 2020-04-16 | Special | PDF ↗ |
| K192398 | Millenium HX | Mar Cor Purification, Inc. | 2019-10-03 | Special | PDF ↗ |
| K182367 | DIASAFEplusUS | Fresenius Medical Care Renal Therapies Group, LLC | 2019-01-10 | Traditional | PDF ↗ |
| K171099 | EON Portable Reverse Osmosis Water Purification System | Cantel | 2018-01-05 | Traditional | PDF ↗ |
| K161304 | EndoPur Filter | Nephros, Inc. | 2017-03-02 | Traditional | PDF ↗ |
| K161844 | Matrix Pre-Treatment Controller | Better Water, LLC | 2016-12-13 | Abbreviated | PDF ↗ |
| K153329 | MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis | Med-Tech Water Systems, Inc. | 2016-08-04 | Traditional | PDF ↗ |
| K143617 | AquaC UNO H | Vivonic GmbH | 2015-10-19 | Traditional | PDF ↗ |
| K151637 | UPT Series Medical RO Water System | Specialty Water Technologies | 2015-09-23 | Traditional | PDF ↗ |
| K142285 | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz | Ameriwater | 2014-12-01 | Traditional | PDF ↗ |
| K133149 | BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM | Mar Cor Purification, Inc. | 2014-04-30 | Traditional | PDF ↗ |
| K133829 | AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF | Vivonic GmbH | 2014-04-22 | Traditional | PDF ↗ |
| K133783 | AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION | Ameriwater | 2014-04-16 | Traditional | PDF ↗ |
| K131904 | MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA | Ameriwater | 2013-11-13 | Traditional | PDF ↗ |
| K131622 | MROZ REVERSE OSMOSIS SYSTEM | Ameriwater | 2013-09-20 | Traditional | PDF ↗ |
| K123282 | DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS | Ultrapure & Industrial Services, LLC | 2013-04-25 | Traditional | PDF ↗ |
| K124059 | AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) | Lauer Membran Wassertechnik GmbH | 2013-03-25 | Traditional | PDF ↗ |
| K121022 | AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV | Ameriwater | 2012-09-17 | Traditional | PDF ↗ |
| K112331 | BIOPURE PORTABLE RO SYSTEMS | Arion Water, Inc. | 2012-07-05 | Traditional | PDF ↗ |
| K111740 | AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION | Ameriwater | 2011-10-05 | Abbreviated | PDF ↗ |
| K110285 | NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER | Nephros, Inc. | 2011-07-14 | Special | PDF ↗ |
| K110578 | MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM | Mar Cor Purification, Inc. | 2011-05-20 | Traditional | PDF ↗ |
| K102892 | ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS | Aqua Sciences, Inc. | 2011-02-03 | Traditional | PDF ↗ |
| K093608 | GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H | Gambro Renal Products, Inc. | 2010-07-29 | Traditional | PDF ↗ |
| K092481 | HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2 | New Aqua, LLC (Dba Aqua Systems) | 2010-04-02 | Traditional | PDF ↗ |
| K083712 | WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS | Dipure, LLC | 2009-07-10 | Traditional | PDF ↗ |
| K090885 | NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER | Nephros, Inc. | 2009-06-29 | Traditional | PDF ↗ |
| K082400 | DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS | Culligan Soft Water Service Co. | 2009-02-03 | Traditional | PDF ↗ |
| K080703 | BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK | 4m Ventures, Inc. | 2008-06-02 | Traditional | PDF ↗ |
| K072158 | AQUA PURE DEIONIZER EXCHANGE SERVICE | Staubach Barror Water Systems, Inc. | 2008-02-21 | Traditional | PDF ↗ |
| K071104 | ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM | Flier'S Quality Water Systems, Inc. | 2008-01-14 | Traditional | PDF ↗ |
| K061782 | GAMBRO POSICLEAR | Gambro Services, Inc. | 2007-01-04 | Traditional | PDF ↗ |
| K060942 | WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS | Bob J. Johnson & Associates | 2006-07-07 | Traditional | PDF ↗ |
| K051620 | MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES | Better Water, Inc. | 2005-11-18 | Abbreviated | PDF ↗ |
| K042018 | ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM | Simply Clean Air & Water, Inc. | 2005-04-15 | Traditional | PDF ↗ |
| K043344 | DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM | Dialysis Services, Inc. | 2005-03-23 | Traditional | PDF ↗ |
| K042797 | WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Gambro Renal Products | 2005-03-09 | Abbreviated | PDF ↗ |
| K041884 | MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Mueller Water Conditioning, Inc. | 2005-02-28 | Traditional | PDF ↗ |
| K042089 | NX STAGE WATER PURIFICATION SYSTEM | Nxstage Medical, Inc. | 2004-11-24 | Traditional | PDF ↗ |
| K031832 | MEGA PURE CART | Mega Services | 2004-10-20 | Traditional | PDF ↗ |
| K041163 | ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES | Isopure, Corp. | 2004-10-07 | Traditional | PDF ↗ |
| K033648 | PERFORMANCE WATER TREATMENT SYSTEM | Performance Water Systems, LLC | 2004-08-09 | Traditional | PDF ↗ |
| K030348 | BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE | Biolab Equipment Canada , Ltd. | 2003-10-21 | Traditional | PDF ↗ |
| K032004 | AQUABOSS ECORO DIA 50 | Lauer Ltd., Hong Kong | 2003-10-02 | Traditional | PDF ↗ |
| K030652 | MEDRO SPD | Usfilter/Ionpure, Inc. | 2003-09-03 | Traditional | PDF ↗ |
| K021560 | MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Ameriwater | 2003-08-14 | Traditional | PDF ↗ |
| K022448 | WATER PURIFICATION SYSTEM | Purity Water Company of San Antonio, Inc. | 2003-05-28 | Traditional | PDF ↗ |
| K030059 | PORTABLE RO+ MODEL MROS09 | Ameriwater | 2003-04-07 | Traditional | PDF ↗ |
| K022747 | HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM | Hydropure Systems, Inc. | 2003-02-11 | Traditional | PDF ↗ |
| K011005 | PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS | Pure Water Solutions, Inc. | 2002-11-01 | Traditional | PDF ↗ |
| K001755 | MPW HEMODIALYSIS WATER PURIFICATION SYSTEM | Mpw Industrial Water Services, Inc. | 2002-08-05 | Abbreviated | PDF ↗ |
| K021352 | DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS | Dayton Water Systems | 2002-08-01 | Special | PDF ↗ |
| K013677 | MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM | Usfilter/Ionpure, Inc. | 2002-03-08 | Special | PDF ↗ |
| K014169 | WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS | Bob J. Johnson & Assoc., Inc. | 2002-02-06 | Traditional | PDF ↗ |
| K003957 | DIACLEAR ULTRAFILTER | Gambro Renal Products | 2001-11-01 | Traditional | PDF ↗ |
| K010592 | AQUA WATER TREATMENT FOR HEMODIALYSIS | Aqua Water Treatment, Inc. | 2001-09-28 | Traditional | PDF ↗ |
| K003877 | MAR COR SERVICES SEMPER PURE RO MACHINE | Mar Cor Services, Inc. | 2001-06-22 | Abbreviated | PDF ↗ |
| K002045 | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Total Water Treatment Systems, Inc. | 2001-02-16 | Traditional | PDF ↗ |
| K994292 | WATER PURIFICATION SYSTEM | Water & Power Technologies, Inc. | 2001-01-02 | Traditional | PDF ↗ |
| K994279 | PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION) | Pure Water Solutions, Inc. | 2000-12-22 | Abbreviated | PDF ↗ |
| K001282 | AIW WATER SYSTEM FOR HEMODIALYSIS | American Industrial Water | 2000-12-15 | Traditional | PDF ↗ |
| K000249 | SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100 | Schaefer Water Centers | 2000-12-11 | Traditional | PDF ↗ |
| K001811 | NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM | Neu-Ion, Inc. | 2000-10-25 | Traditional | PDF ↗ |
| K991495 | FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS | Fluid Process Systems, Inc. | 2000-08-28 | Traditional | PDF ↗ |
| K993806 | DIALGUARD ENDOTOXIN REMOVAL DEVICE | Clarigen, Inc. | 2000-08-14 | Traditional | PDF ↗ |
| K993877 | NELSON WATER SYSTEMS FOR HEMODIALYSIS | Nelson Environmental Technologies, Inc. | 2000-05-25 | Traditional | PDF ↗ |
| K993520 | H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Serv-A-Pure Co. | 2000-05-03 | Traditional | PDF ↗ |
| K991519 | AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Ameriwater | 2000-04-14 | Traditional | PDF ↗ |
| K992786 | PURE WATER, INC.'S WATER PURIFICATION SYSTEMS | Pure Water, Inc. | 2000-01-24 | Traditional | PDF ↗ |
| K993200 | MD 420/440/460/470/480/490 | Isopure, Corp. | 2000-01-24 | Traditional | PDF ↗ |
| K991916 | VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Virginia Water Systems, Inc. | 2000-01-14 | Traditional | PDF ↗ |
| K983239 | WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS | Rasco | 1999-11-18 | Traditional | PDF ↗ |
| K983512 | WATER TREATMENT SYSTEM FOR HEMODIALYSIS | Water Vault, Inc. | 1999-04-28 | Traditional | PDF ↗ |
| K983126 | FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS | Minntech Corp. | 1999-03-08 | Traditional | PDF ↗ |
| K981680 | ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS | Dayton Water Systems | 1998-12-31 | Traditional | PDF ↗ |
| K980182 | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Usfilter/Ionpure, Inc. | 1998-11-16 | Traditional | PDF ↗ |
| K974899 | GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H | Gambro Healthcare | 1998-09-23 | Traditional | PDF ↗ |
| K981085 | GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM | Gambro Healthcare | 1998-05-18 | Traditional | PDF ↗ |
| K974127 | HYDRA METER | Automata Instrumentation, Inc. | 1997-12-19 | Traditional | PDF ↗ |
| K964539 | PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST | Zyzatech Water Systems, Inc. | 1997-11-26 | Traditional | PDF ↗ |
| K945559 | MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS | Mar Cor Services, Inc. | 1996-05-28 | Traditional | PDF ↗ |
| K944493 | REVERSE OSMOSIS SYSTEM | G.E.M. Water Systems | 1996-02-20 | Traditional | PDF ↗ |
| K954928 | PORTABLE REVERSE OSMOSIS MACHINE | Better Water, Inc. | 1996-01-24 | Traditional | PDF ↗ |
| K954349 | FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS | Minntech Corp. | 1995-12-15 | Traditional | PDF ↗ |
| K945066 | AWESMOSIS | Applied Water Engineering, Inc. | 1995-12-15 | Traditional | PDF ↗ |
| K944767 | DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER | Fresenius USA, Inc. | 1995-11-29 | Traditional | PDF ↗ |
| K924695 | ASEPTECH PORTABLE RO+ SYSTEM | Dayton Water Systems | 1995-08-24 | Traditional | PDF ↗ |
| K952215 | SERIM HISENSE TEST KIT | Serim Research Corp. | 1995-08-09 | Traditional | PDF ↗ |
| K920186 | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Better Water, Inc. | 1995-06-13 | Traditional | PDF ↗ |
| K944385 | MD400 A/B/C/D/E/F/G | International Purification Systems, Inc. | 1995-04-28 | Traditional | PDF ↗ |
Product code FIP · Class II · Gastroenterology, Urology. Data: openFDA.