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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: DTR FDA class 2

    Heat-Exchanger, Cardiopulmonary Bypass

    Cardiovascular

    View full classification →

    The Cardiopulmonary Bypass Heat-Exchanger is a life-sustaining cardiovascular device used to regulate the temperature of blood as it passes through the extracorporeal circuit, enabling deliberate cooling and rewarming of the patient during open-heart surgery. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTR and it is regulated under 21 CFR 870.4240 within the Cardiovascular medical specialty. This device is designated as life-sustaining or life-supporting.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
    VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)
    MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
    Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
    Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
    Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger
    MPS 3 ND Myocardial Protection System
    MPS 3 Myocardial Protection System
    MPS2 Myocardial Protection System Console
    MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)
    MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge
    PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
    GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
    PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30
    MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
    VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS COATING
    CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200
    SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
    VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER
    MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
    COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
    CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B
    ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
    CAPIOX CARDIOPLEGIA
    CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)
    VISION CARDIOPLEGIA DELIVERY SYSTEM
    S3 CARDIOPLEGIA CONTROL
    MYOCARDIAL PROTECTION SYSTEM
    SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS
    HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA
    ELECTROMEDICS BLOOD HEAT EXCHANGER
    ROTATOR;MALE-MALE, MALE-FEMALE
    HE-30 GOLD
    BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS
    CONDUCER HEAT EXCHANGER
    LANCASTER COOLING JACKET, CAT. CODE #13500/13501
    CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES
    MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF
    MYOCARDIAL PROTECTION SYSTEM
    BCD ADVANCED
    TOPICAL COOLING PAD, MODEL 7000
    SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEM
    SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM
    EXTRACORPOREAL HEAT EXCHANGER HE SERIES
    MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU
    SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)
    SCIMED ECMOTHERM(TM) HEAT EXCHANGER
    SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM
    INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM
    BASIC HEATER-COOLER UNIT, 115/100V 16-02-20

    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.

    Popular Product Codes

    Commonly searched
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