ClearanceBrief
Panels › Gastroenterology, Urology › Product code FIP · Class 2

Subsystem, Water Purification

Regulation 876.5665

1510(k)s in 12 months (117 all time)
0recalls in 12 months (15 all time)
15recalls that name a 510(k)
Get daily alerts for FIPSample briefCSV

Top companies in FIP

Company510(k)sRecalls
AmeriWater, LLC102
Fresenius Medical Care Holdings, Inc.08
Mar Cor Purification, Inc.43
Better Water, Inc.40
Fresenius Medical Care Renal Therapies Group, LLC40
Dayton Water Systems30
Gambro Renal Products30
Minntech Corp.30
Nephros, Inc.30
Usfilter/Ionpure, Inc.30
Decided510(k)Device and applicantCode
Nov 14, 2025K250471AquaC UNO H
Fresenius Medical Care Renal Therapies Group, LLC
FIP
Oct 9, 2025K251851DIASAFEplusUS (F00013010)
Fresenius Medical Care Renal Therapies Group, LLC
FIP
Sep 9, 2025K252181AquaA
Fresenius Medical Care North America
FIP
Mar 17, 2025K250514UPT Series Medical RO Water Treatment System
Specialty Water Technologies, Inc.
FIP
Jun 13, 2024K232953AquaBplus; AquaB LITE
Fresenius Medical Care Renal Therapies Group, LLC
FIP
Aug 16, 2023K223479AQUAbase nX
B.Braun Medical, Inc.
FIP
Jul 19, 2023K231410RenaPure Endotoxin Retentive Filter
Evoqua Water Technologies, LLC
FIP
Feb 13, 2023K223656AmeriWater MediQA Reverse Osmosis System (MSP3HF)
AmeriWater, LLC
FIP
Jul 27, 2022K213507AquaA
Fresenius Medical Care Rental Therapies Group, LLC
FIP
Oct 19, 2021K211035U9000 Plus Ultrafilter
Baxter Healthcare Corporation
FIP
Apr 16, 2020K200670EON Portable RO Water Purification System
Mar Cor Purification, Inc.
FIP
Oct 3, 2019K192398Millenium HX
Mar Cor Purification, Inc.
FIP
Jan 10, 2019K182367DIASAFEplusUS
Fresenius Medical Care Renal Therapies Group, LLC
FIP
Jan 5, 2018K171099EON Portable Reverse Osmosis Water Purification System
Cantel
FIP
Mar 2, 2017K161304EndoPur Filter
Nephros, Inc.
FIP
Dec 13, 2016K161844Matrix Pre-Treatment Controller
Better Water, LLC
FIP
Aug 4, 2016K153329MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis
Med-Tech Water Systems, Inc.
FIP
Oct 19, 2015K143617AquaC UNO H
Vivonic GmbH, DE
FIP
Sep 23, 2015K151637UPT Series Medical RO Water System
Specialty Water Technologies
FIP
Dec 1, 2014K142285AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60h
Ameriwater
FIP
Apr 30, 2014K133149BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM
Mar Cor Purification, Inc.
FIP
Apr 22, 2014K133829AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
Vivonic GmbH, DE
FIP
Apr 16, 2014K133783AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION
Ameriwater
FIP
Nov 13, 2013K131904MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA
Ameriwater
FIP
Sep 20, 2013K131622MROZ REVERSE OSMOSIS SYSTEM
Ameriwater
FIP
Apr 25, 2013K123282DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS
Ultrapure & Industrial Services, LLC
FIP
Mar 25, 2013K124059AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)
Lauer Membran Wassertechnik GmbH, DE
FIP
Sep 17, 2012K121022AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV
Ameriwater
FIP
Jul 5, 2012K112331BIOPURE PORTABLE RO SYSTEMS
Arion Water, Inc.
FIP
Oct 5, 2011K111740AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
Ameriwater
FIP
Jul 14, 2011K110285NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
Nephros, Inc.
FIP
May 20, 2011K110578MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM
Mar Cor Purification, Inc.
FIP
Feb 3, 2011K102892ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
Aqua Sciences, Inc.
FIP
Jul 29, 2010K093608GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
Gambro Renal Products, Inc.
FIP
Apr 2, 2010K092481HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
New Aqua, LLC (Dba Aqua Systems)
FIP
Jul 10, 2009K083712WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
Dipure, LLC
FIP
Jun 29, 2009K090885NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER
Nephros, Inc.
FIP
Feb 3, 2009K082400DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
Culligan Soft Water Service Co.
FIP
Jun 2, 2008K080703BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK
4m Ventures, Inc.
FIP
Feb 21, 2008K072158AQUA PURE DEIONIZER EXCHANGE SERVICE
Staubach Barror Water Systems, Inc.
FIP
Jan 14, 2008K071104ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
Flier'S Quality Water Systems, Inc.
FIP
Jan 4, 2007K061782GAMBRO POSICLEAR
Gambro Services, Inc.
FIP
Jul 7, 2006K060942WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
Bob J. Johnson & Associates
FIP
Nov 18, 2005K051620MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES
Better Water, Inc.
FIP
Apr 15, 2005K042018ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
Simply Clean Air & Water, Inc.
FIP
Mar 23, 2005K043344DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM
Dialysis Services, Inc.
FIP
Mar 9, 2005K042797WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Gambro Renal Products
FIP
Feb 28, 2005K041884MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Mueller Water Conditioning, Inc.
FIP
Nov 24, 2004K042089NX STAGE WATER PURIFICATION SYSTEM
Nxstage Medical, Inc.
FIP
Oct 20, 2004K031832MEGA PURE CART
Mega Services
FIP

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.