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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: FIP FDA class 2

    Subsystem, Water Purification

    Gastroenterology, Urology

    View full classification →

    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.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    UPT Series Medical RO Water Treatment System
    AquaBplus; AquaB LITE
    AQUAbase nX
    RenaPure Endotoxin Retentive Filter
    AmeriWater MediQA Reverse Osmosis System (MSP3HF)
    AquaA
    U9000 Plus Ultrafilter
    EON Portable RO Water Purification System
    Millenium HX
    DIASAFEplusUS
    EON Portable Reverse Osmosis Water Purification System
    EndoPur Filter
    Matrix Pre-Treatment Controller
    MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis
    AquaC UNO H
    UPT Series Medical RO Water System
    AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz
    BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM
    AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF
    AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION
    MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA
    MROZ REVERSE OSMOSIS SYSTEM
    DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS
    AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)
    AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV
    BIOPURE PORTABLE RO SYSTEMS
    AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
    NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
    MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM
    ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
    GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
    HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
    WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
    NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER
    DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
    BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK
    AQUA PURE DEIONIZER EXCHANGE SERVICE
    ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
    GAMBRO POSICLEAR
    WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
    MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES
    ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
    DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM
    WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
    MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
    NX STAGE WATER PURIFICATION SYSTEM
    MEGA PURE CART
    ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
    PERFORMANCE WATER TREATMENT SYSTEM
    BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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