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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: DSA FDA class 2

    Cable, Transducer And Electrode, Patient, (Including Connector)

    Cardiovascular

    View full classification →

    The Patient Transducer and Electrode Cable (including Connector) is a cardiovascular accessory device used to connect patient electrodes or transducers to monitoring, recording, or diagnostic equipment, transmitting physiological signals with minimal interference. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DSA and it is regulated under 21 CFR 870.2900 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SpO2 Extension Cable
    Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn
    RT Carbon ECG Leads
    LIFEPAK® ECG Cables
    LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)
    Fogg System Patient Monitoring Cables
    RFP-100A Connector Cable (Single Use)
    SpO2 Extension Cable
    Med-link Disposable ECG Cable and Leadwires
    9Line
    Multi-Link X2 ECG Cable and Leadwire System
    Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
    PCA-C1 series Patient Cable
    Patient Monitoring Cables
    Multi-LinkTM X2 ECG Adapter and Leadwires
    ECG Cables and Leadwires
    AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector
    Patient Monitoring Cable (SpO2 Extension Cable)
    Disposable ECG Cable
    SureLead Cable System
    ECG Cable
    Multi-Link X2 ECG and SpO2 Adapter
    IntraSight
    Patient Cables and Leadwires , Disposable ECG Leadwires
    Curbell branded Patient Monitoring Cables
    Medline Patient Cables and Lead Wires
    ECG Cable/Leadwires
    Fixed Patient Leads ECG Cable (Model 3153)
    ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables
    Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System
    ECG Disposable Lead Wire
    Multi-Link X2 ECG Cable and Lead Wire System
    Caremed patient cable and leadwires
    Disposable Temporary Pacing Cable
    Unimed Disposable ECG lead wires
    REMOVABLE PATIENT LEADS ECG CABLE
    CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)
    PHILIPS ECG LEADWIRE SET
    TYCO ELECTRONICS ELECTROCARDIOGRAPH (ECG) LEADWIRE SET
    ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8
    PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A
    ADAGIO RETRACTING ECG LEAD WIRES
    MULTLINK CABLE AND LEADWIRE SYSTEM
    PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE MONITORS
    CURBELL PATIENT MONITORING CABLES
    PATIENT CABLE
    SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL
    FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01
    LIFESYNC ADAPTER, MODEL LS-302
    ECG CABLES, TRUNK AND PATIENT LEAD WIRES

    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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