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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: DQK FDA class 2

    Computer, Diagnostic, Programmable

    Cardiovascular

    View full classification →

    The Programmable Diagnostic Computer is a cardiovascular computing device capable of processing and analyzing physiological data from multiple inputs to assist clinicians in cardiovascular diagnosis and patient management. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DQK and it is regulated under 21 CFR 870.1425 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    OneStim-DUO Cardiac Stimulator (MP5003-4CO)
    Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)
    ZEUS Platform (FG0501US)
    EnSite™ X EP System
    ACORYS MAPPING SYSTEM
    Synchrony
    HemoSphere Nano Monitor (HSNANO1)
    CARTO™ 3 EP Navigation System V8.4
    IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)
    Holter ECG and ABP system (HolterABP)
    SafeBeat Rx App
    NorthStar™ Mapping System
    CARTO™ 3 EP Navigation System V9.0 with PIU Plus
    STAR Apollo™ Mapping System
    HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
    DeepRhythmAI
    Vektor Computational ECG Mapping System (vMap®)
    LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub
    CoroFlow Cardiovascular System
    HemoSphere Stream Module
    EnSite™ X EP System
    Volta AF-Xplorer II
    EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)
    CARTO™ 3 EP Navigation System V8.1
    EnSite™ X EP System
    HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)
    Globe® Pulsed Field System
    PhysCade System
    OptiMap™ System
    DeepRhythmAI
    Volta AF-Xplorer
    VitalRhythm
    Intra-Operative Positioning System (IOPS®)
    CER-S
    Affera Integrated Mapping System
    Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
    Magnetic Localization Patch Kit (AFR-00021)
    DeepRhythmAI
    Affera Integrated Mapping System; Impedance Localization Patch Kit
    Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)
    RHYTHMIA HDx™ Mapping System
    HeartKey® Rhythm
    EnSite™ X EP System
    STAR Apollo™ Mapping System
    Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)
    Merge Hemo, Model RCSV2
    LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub
    Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
    CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
    NeuTrace EP Mapping System v.2.1

    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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