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: LDD FDA class 2

    Dc-Defibrillator, Low-Energy, (Including Paddles)

    Cardiovascular

    View full classification →

    A low-energy DC defibrillator with paddles is a cardiovascular device used to deliver controlled electrical shocks to the heart to terminate life-threatening arrhythmias such as ventricular fibrillation or pulseless ventricular tachycardia. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is LDD, regulated under 21 CFR 870.5300, in the Cardiovascular specialty. This device is designated as life sustaining or life supporting, reflecting its critical role in emergency cardiac care.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Switched Internal Paddles
    Tempus LS - Manual
    Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors
    Rapid Hair Removal Pads
    ZOLL E SERIES ALS
    CARDIOMED
    EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC
    CARDIO MED
    CARDIO MED MODEL A102, H104, O101, P103, AND Z100
    ZOLL PROPAQ MD
    ZOLL PROPAQ MD
    HEART SYNC PEDIATRIC, MODEL PED-100
    ZOLL R SERIES
    ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE
    ZOLL AUTOCLAVABLE INTERNAL HANDLES
    DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES
    ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR
    MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER
    BOOKER BOX, MODEL PAD 5010
    ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP9
    NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES
    NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES
    NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES
    V2
    ZOLL AUTOCLAVABLE INTERNAL HANDLES
    700-F SERIES STIMULATION ELECTRODES
    CARDIOSERV S
    CARDIO SERV
    DPD DEFIBRILLATOR
    UNIPOWER RECHARGEABLE BATTERY PACK
    NCE REPLACEMENT BATTERIES
    PEDIATRIC DEFIB K-PADS
    UNIPOWERR RECHARGEABLE BATTERY PACK
    VITAL-COMBO(R)
    RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB
    BATTERY PACK# S1024NC
    BATTERY PACK #1012NC
    LIFEPAK 9 DEFIBRILLATOR/MONITOR
    ZOLL PD 5300
    5200 ADULT SOLID GEL MULTI-FUNCTION ELECTRODES
    ZOLL PD 5200C ADULT SOLID GEL MULTI-FUNCTION ELECT
    ZOLL D 5400 ADULT SOLID GEL DEFIBRILLATION ELECTRO
    CARDIAC THERAPHY SYSTEM SCP 900
    DPD DEFIBRILLATOR
    LIFEPAK 10 DEFIBRILLATOR/MONITOR W/OPT PACEMAKER
    PRIMEDIC DEFIBRILLATORS-N/B
    MARQUETTE SERIES 360 DEFIBRILLATOR
    BATTERY PACK
    MODEL #340 STEALTH-TRODE+LS
    LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR)

    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