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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: BSO FDA class 2

    Catheter, Conduction, Anesthetic

    Anesthesiology

    View full classification →

    The Catheter, Conduction, Anesthetic is a flexible catheter used to deliver local anesthetic agents to a specific nerve or anatomical region for regional anesthesia or continuous nerve block. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BSO, regulated under 21 CFR 868.5120 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    EDEN ControlCath
    Perifix FX Catheter; Contiplex FX Catheter
    Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)
    SubQKath Catheter and Needle Set
    Percutaneous Introducer
    C-CAT Anaesthesia Catheter kit
    Medline Reinforced Epidural Catheter
    EPINAUT
    Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
    B. Braun Tear-Away Introducer Needle
    Certa Catheter
    UltraCath Continuous Nerve block Catheter
    ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit
    Perifix and Contiplex Catheter
    E-Cath
    Medline Epidural Catheter
    SPINAUT-E, SPINAUT-I
    FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET
    ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
    SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
    VITAL 5 RELEAF CATHETER
    PAINFUSOR CATHETER
    AMBIT TUNNELER
    IO-FLEX CATHETER
    AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH
    BUSSE EPIDURAL CATHETER KIT
    PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.
    SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT
    PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT
    STRYKER ANTIMIC CATHETER
    PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS
    BUSSE EPIDURAL CATHETER
    ON-Q INTRODUCERS
    PORTEX EPIDURAL CATHETER
    ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER
    LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216
    AMT NANOCATH
    MODIFICATION TO SOAKER CATHETER
    PERIFIX CATHETER AND CONTIPLEX CATHETER
    MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
    VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
    EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
    PERIFIX CATHETER CONNECTOR
    TE ME NA EPIDURAL CATHETER
    SPIROL EPIDURAL CATHETER
    MICOR CONDUCTION CATHETER
    AXIOM MULTIPURPOSE WOUND DRAIN
    SPRING-WOUND EPIDURAL CATHETER
    SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18
    FETH-R-KATH

    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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