Product Code: FIP FDA class 2 21 CFR 876.5665

Subsystem, Water Purification

Gastroenterology, Urology

The Water Purification Subsystem is a component of a hemodialysis water treatment system that removes contaminants from source water to meet the quality standards required for safe preparation of dialysate. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party 510(k) review. The product code is FIP, regulated under 21 CFR 876.5665, within the Gastroenterology, Urology specialty.

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510(k)s

117

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FIP
Device Class: FDA class 2
Regulation Number: 876.5665
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 117 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250471	AquaC UNO H	Nov 14, 2025	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K251851	DIASAFEplusUS (F00013010)	Oct 09, 2025	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K252181	AquaA	Sep 09, 2025	Substantially Equivalent	Fresenius Medical Care North America
K250514	UPT Series Medical RO Water Treatment System	Mar 17, 2025	Substantially Equivalent	Specialty Water Technologies, Inc.
K232953	AquaBplus; AquaB LITE	Jun 13, 2024	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K223479	AQUAbase nX	Aug 16, 2023	Substantially Equivalent	B.Braun Medical, Inc.
K231410	RenaPure Endotoxin Retentive Filter	Jul 19, 2023	Substantially Equivalent	Evoqua Water Technologies, LLC
K223656	AmeriWater MediQA Reverse Osmosis System (MSP3HF)	Feb 13, 2023	Substantially Equivalent	AmeriWater, LLC
K213507	AquaA	Jul 27, 2022	Substantially Equivalent	Fresenius Medical Care Rental Therapies Group, LLC
K211035	U9000 Plus Ultrafilter	Oct 19, 2021	Substantially Equivalent	Baxter Healthcare Corporation
K200670	EON Portable RO Water Purification System	Apr 16, 2020	Substantially Equivalent	Mar Cor Purification, Inc.
K192398	Millenium HX	Oct 03, 2019	Substantially Equivalent	Mar Cor Purification, Inc.
K182367	DIASAFEplusUS	Jan 10, 2019	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC
K171099	EON Portable Reverse Osmosis Water Purification System	Jan 05, 2018	Substantially Equivalent	Cantel
K161304	EndoPur Filter	Mar 02, 2017	Substantially Equivalent	Nephros, Inc.
K161844	Matrix Pre-Treatment Controller	Dec 13, 2016	Substantially Equivalent	Better Water, LLC
K153329	MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis	Aug 04, 2016	Substantially Equivalent	Med-Tech Water Systems, Inc.
K143617	AquaC UNO H	Oct 19, 2015	Substantially Equivalent	Vivonic GmbH
K151637	UPT Series Medical RO Water System	Sep 23, 2015	Substantially Equivalent	Specialty Water Technologies
K142285	AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz	Dec 01, 2014	Substantially Equivalent	Ameriwater
K133149	BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM	Apr 30, 2014	Substantially Equivalent	Mar Cor Purification, Inc.
K133829	AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF	Apr 22, 2014	Substantially Equivalent	Vivonic GmbH
K133783	AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION	Apr 16, 2014	Substantially Equivalent	Ameriwater
K131904	MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA	Nov 13, 2013	Substantially Equivalent	Ameriwater
K131622	MROZ REVERSE OSMOSIS SYSTEM	Sep 20, 2013	Substantially Equivalent	Ameriwater
K123282	DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS	Apr 25, 2013	Substantially Equivalent	Ultrapure & Industrial Services, LLC
K124059	AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)	Mar 25, 2013	Substantially Equivalent	Lauer Membran Wassertechnik GmbH
K121022	AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV	Sep 17, 2012	Substantially Equivalent	Ameriwater
K112331	BIOPURE PORTABLE RO SYSTEMS	Jul 05, 2012	Substantially Equivalent	Arion Water, Inc.
K111740	AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION	Oct 05, 2011	Substantially Equivalent	Ameriwater
K110285	NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER	Jul 14, 2011	Substantially Equivalent	Nephros, Inc.
K110578	MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM	May 20, 2011	Substantially Equivalent	Mar Cor Purification, Inc.
K102892	ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS	Feb 03, 2011	Substantially Equivalent	Aqua Sciences, Inc.
K093608	GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H	Jul 29, 2010	Substantially Equivalent	Gambro Renal Products, Inc.
K092481	HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2	Apr 02, 2010	Substantially Equivalent	New Aqua, LLC (Dba Aqua Systems)
K083712	WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS	Jul 10, 2009	Substantially Equivalent	Dipure, LLC
K090885	NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER	Jun 29, 2009	Substantially Equivalent	Nephros, Inc.
K082400	DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS	Feb 03, 2009	Substantially Equivalent	Culligan Soft Water Service Co.
K080703	BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK	Jun 02, 2008	Substantially Equivalent	4m Ventures, Inc.
K072158	AQUA PURE DEIONIZER EXCHANGE SERVICE	Feb 21, 2008	Substantially Equivalent	Staubach Barror Water Systems, Inc.
K071104	ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM	Jan 14, 2008	Substantially Equivalent	Flier'S Quality Water Systems, Inc.
K061782	GAMBRO POSICLEAR	Jan 04, 2007	Substantially Equivalent	Gambro Services, Inc.
K060942	WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS	Jul 07, 2006	Substantially Equivalent	Bob J. Johnson & Associates
K051620	MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES	Nov 18, 2005	Substantially Equivalent	Better Water, Inc.
K042018	ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM	Apr 15, 2005	Substantially Equivalent	Simply Clean Air & Water, Inc.
K043344	DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM	Mar 23, 2005	Substantially Equivalent	Dialysis Services, Inc.
K042797	WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS	Mar 09, 2005	Substantially Equivalent	Gambro Renal Products
K041884	MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS	Feb 28, 2005	Substantially Equivalent	Mueller Water Conditioning, Inc.
K042089	NX STAGE WATER PURIFICATION SYSTEM	Nov 24, 2004	Substantially Equivalent	Nxstage Medical, Inc.
K031832	MEGA PURE CART	Oct 20, 2004	Substantially Equivalent	Mega Services
K041163	ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES	Oct 07, 2004	Substantially Equivalent	Isopure, Corp.
K033648	PERFORMANCE WATER TREATMENT SYSTEM	Aug 09, 2004	Substantially Equivalent	Performance Water Systems, LLC
K030348	BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE	Oct 21, 2003	Substantially Equivalent	Biolab Equipment Canada , Ltd.
K032004	AQUABOSS ECORO DIA 50	Oct 02, 2003	Substantially Equivalent	Lauer Ltd., Hong Kong
K030652	MEDRO SPD	Sep 03, 2003	Substantially Equivalent	Usfilter/Ionpure, Inc.
K021560	MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS	Aug 14, 2003	Substantially Equivalent	Ameriwater
K022448	WATER PURIFICATION SYSTEM	May 28, 2003	Substantially Equivalent	Purity Water Company of San Antonio, Inc.
K030059	PORTABLE RO+ MODEL MROS09	Apr 07, 2003	Substantially Equivalent	Ameriwater
K022747	HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM	Feb 11, 2003	Substantially Equivalent	Hydropure Systems, Inc.
K011005	PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS	Nov 01, 2002	Substantially Equivalent	Pure Water Solutions, Inc.
K001755	MPW HEMODIALYSIS WATER PURIFICATION SYSTEM	Aug 05, 2002	Substantially Equivalent	Mpw Industrial Water Services, Inc.
K021352	DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS	Aug 01, 2002	Substantially Equivalent	Dayton Water Systems
K013677	MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM	Mar 08, 2002	Substantially Equivalent	Usfilter/Ionpure, Inc.
K014169	WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS	Feb 06, 2002	Substantially Equivalent	Bob J. Johnson & Assoc., Inc.
K003957	DIACLEAR ULTRAFILTER	Nov 01, 2001	Substantially Equivalent	Gambro Renal Products
K010592	AQUA WATER TREATMENT FOR HEMODIALYSIS	Sep 28, 2001	Substantially Equivalent	Aqua Water Treatment, Inc.
K003877	MAR COR SERVICES SEMPER PURE RO MACHINE	Jun 22, 2001	Substantially Equivalent	Mar Cor Services, Inc.
K002045	WATER PURIFICATION SYSTEM FOR HEMODIALYSIS	Feb 16, 2001	Substantially Equivalent	Total Water Treatment Systems, Inc.
K994292	WATER PURIFICATION SYSTEM	Jan 02, 2001	Substantially Equivalent	Water & Power Technologies, Inc.
K994279	PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)	Dec 22, 2000	Substantially Equivalent	Pure Water Solutions, Inc.
K001282	AIW WATER SYSTEM FOR HEMODIALYSIS	Dec 15, 2000	Substantially Equivalent	American Industrial Water
K000249	SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100	Dec 11, 2000	Substantially Equivalent	Schaefer Water Centers
K001811	NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM	Oct 25, 2000	Substantially Equivalent	Neu-Ion, Inc.
K991495	FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS	Aug 28, 2000	Substantially Equivalent	Fluid Process Systems, Inc.
K993806	DIALGUARD ENDOTOXIN REMOVAL DEVICE	Aug 14, 2000	Substantially Equivalent	Clarigen, Inc.
K993877	NELSON WATER SYSTEMS FOR HEMODIALYSIS	May 25, 2000	Substantially Equivalent	Nelson Environmental Technologies, Inc.
K993520	H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS	May 03, 2000	Substantially Equivalent	Serv-A-Pure Co.
K991519	AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS	Apr 14, 2000	Substantially Equivalent	Ameriwater
K993200	MD 420/440/460/470/480/490	Jan 24, 2000	Substantially Equivalent	Isopure, Corp.
K992786	PURE WATER, INC.'S WATER PURIFICATION SYSTEMS	Jan 24, 2000	Substantially Equivalent	Pure Water, Inc.
K991916	VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS	Jan 14, 2000	Substantially Equivalent	Virginia Water Systems, Inc.
K983239	WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS	Nov 18, 1999	Substantially Equivalent	Rasco
K983512	WATER TREATMENT SYSTEM FOR HEMODIALYSIS	Apr 28, 1999	Substantially Equivalent	Water Vault, Inc.
K983126	FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS	Mar 08, 1999	Substantially Equivalent	Minntech Corp.
K981680	ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS	Dec 31, 1998	Substantially Equivalent	Dayton Water Systems
K980182	WATER PURIFICATION SYSTEM FOR HEMODIALYSIS	Nov 16, 1998	Substantially Equivalent	Usfilter/Ionpure, Inc.
K974899	GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H	Sep 23, 1998	Substantially Equivalent	Gambro Healthcare
K981085	GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM	May 18, 1998	Substantially Equivalent	Gambro Healthcare
K974127	HYDRA METER	Dec 19, 1997	Substantially Equivalent	Automata Instrumentation, Inc.
K964539	PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST	Nov 26, 1997	Substantially Equivalent	Zyzatech Water Systems, Inc.
K945559	MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS	May 28, 1996	Substantially Equivalent	Mar Cor Services, Inc.
K944493	REVERSE OSMOSIS SYSTEM	Feb 20, 1996	Substantially Equivalent	G.E.M. Water Systems
K954928	PORTABLE REVERSE OSMOSIS MACHINE	Jan 24, 1996	Substantially Equivalent	Better Water, Inc.
K954349	FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS	Dec 15, 1995	Substantially Equivalent	Minntech Corp.
K945066	AWESMOSIS	Dec 15, 1995	Substantially Equivalent	Applied Water Engineering, Inc.
K944767	DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER	Nov 29, 1995	Substantially Equivalent	Fresenius USA, Inc.
K924695	ASEPTECH PORTABLE RO+ SYSTEM	Aug 24, 1995	Substantially Equivalent	Dayton Water Systems
K952215	SERIM HISENSE TEST KIT	Aug 09, 1995	Substantially Equivalent	Serim Research Corp.
K920186	WATER PURIFICATION SYSTEM FOR HEMODIALYSIS	Jun 13, 1995	Substantially Equivalent	Better Water, Inc.
K944385	MD400 A/B/C/D/E/F/G	Apr 28, 1995	Substantially Equivalent	International Purification Systems, Inc.
K945136	RENAGUARD DIALYSATE FILTER	Feb 28, 1995	Substantially Equivalent	Minntech Corp.
K931595	REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION	Dec 29, 1994	Substantially Equivalent	Osmonics, Inc.
K934848	MASTER ALERT	Sep 29, 1994	Substantially Equivalent	Master Hydro Systems, Inc.
K915258	SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM	Jul 02, 1993	Substantially Equivalent	Aqua-Med Systems, Inc.
K894300	SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS	Mar 13, 1990	Substantially Equivalent	U.S. Filter/Continental Water Systems
K894106	DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST	Nov 08, 1989	Substantially Equivalent	Cd Medical, Inc.
K871242	REVERSE OSMOSIS WATER PURIFICATION SYSTEM	Mar 16, 1988	Substantially Equivalent	Medro Systems, Inc.
K873487	HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES	Oct 23, 1987	Substantially Equivalent	Water Pure, Inc.
K863720	HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES	Oct 29, 1986	Substantially Equivalent	Water Pure, Inc.
K842215	ASCORBIC ACID	Aug 02, 1984	Substantially Equivalent	Organon Teknika Corp.
K841403	HEMO-RO WATER PURIFICATION SYS	Jul 06, 1984	Substantially Equivalent	Millipore Corp.
K822385	EXTRAPURE REVERSE OSMOSIS WATER UNIT	Oct 13, 1982	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K811678	GAMBRO WATER PURIFICATION MONITOR WRD	Jul 10, 1981	Substantially Equivalent	Gambro, Inc.
K802474	CMR 300, ROWATER TREATMENT UNIT	Dec 15, 1980	Substantially Equivalent	U-Marc, Inc.
K800305	WATER CONDUCTIVITY MONITOR & CONTROLLER	Apr 08, 1980	Substantially Equivalent	Darco Water Systems, Inc.
K791086	CENTRY 2 SYSTEM #016, 103, 016, 104	Jul 03, 1979	Substantially Equivalent	Cobe Laboratories, Inc.
K771763	HEMO-RO	Oct 04, 1977	Substantially Equivalent	Millipore Corp.