BEUDAMED
    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: MKJ FDA class 3

    Automated External Defibrillators (Non-Wearable)

    Cardiovascular

    View full classification →

    The Non-Wearable Automated External Defibrillator (AED) is a portable prescription-use-only device that automatically analyzes a patient's cardiac rhythm and, when a shockable rhythm such as ventricular fibrillation or pulseless ventricular tachycardia is detected, delivers a defibrillation shock to restore normal cardiac rhythm, intended for use in clinical or emergency settings rather than worn on the patient's body. Classified as a Class 3 device under 21 CFR 870.5310 within the Cardiovascular specialty, it requires Premarket Approval (PMA). It carries no implant flag but is a critical life-saving device used in cardiac emergencies.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Powerheart G5 AED
    OneStep Pediatric CPR Multi-Function Electrode
    CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel
    samaritan PAD 450P
    HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORING
    ZOLL E SERIES
    LIFEPAK 15 monitor/defibrillator
    BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500
    ZOLL X Series
    Skintact, various other tradenames
    ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY
    ZOLL X SERIES
    ONESTEP CPR II MULTI-FUNCTION ELECTRODE
    ZOLL X SERIES
    ZOLL X SERIES
    SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
    POWERHEART G5 AED
    HEART SYNC
    PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
    HEART SYNC
    LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR
    HEARTSINE SAMARITAN PAD 350P
    HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
    DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
    ZOLL SUREPOWER SINGLE BAY CHARGER
    DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
    EXTENDED LIFE BATTERY
    ZOLL FULLY AUTOMATIC AED PLUS
    LIFEPAK 1000 DEFIBRILLATOR
    ZOLL R SERIES
    HEART SYNC PEDIATRIC PHYSIO AED PAD
    ZOLL PROPAQ MD
    ZOLL X SERIES
    PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES
    PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
    ZOLL E SERIES
    POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS
    ONESTEP PEDIATRIC MFE'S
    ONESTEP ADULT MULTI-FUNCTION ELECTRODE
    ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
    LIFEPAK 15 MONITOR/DEFIBRILLATOR
    ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
    ZOLL AED PLUS WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
    ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
    SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES
    LIFEPAK 12
    DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325
    ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE
    MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED
    ZOLL E SERIES WITH CPRREADYCHARGE

    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
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump