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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: CAZ FDA class 2

    Anesthesia Conduction Kit

    Anesthesiology

    View full classification →

    The Anesthesia Conduction Kit is a preassembled convenience kit containing the components needed to perform conduction (regional) anesthesia procedures, such as nerve blocks or epidural anesthesia. It is classified as FDA Class 2 (moderate risk); however, per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance, this type of kit is under enforcement discretion and does not require a 510(k) premarket notification if it meets all criteria in that guidance. The product code is CAZ, regulated under 21 CFR 868.5140, within the Anesthesiology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Arrow 0.2 Micron Flat Filter, GVS
    BD Epilor Syringe
    Plastic LOR Syringe
    E-Cath STIM acc. Tsui
    VPC
    Arrow Epidural Catheter Kit
    ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set
    Arrow Epidural Catheter Kit
    ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE
    CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT
    ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
    PERIFUSE CATHETER
    CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
    FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER
    FENESTRATED NERVE BLOCK NEEDLE
    SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG
    CONTIPLEX FX
    ECHOBRIGHT
    PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,
    ECHOBRIGHT
    EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
    B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET
    PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF
    PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE PERIPHERAL PLEXUS: SINGLE SHOT
    BUSSE PLASTIC LOR SYRINGE
    PERIPHERAL NERVE BLOCK SUPPORT TRAY
    CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET
    PAJUNKS EPILONG SET PEDIATRIC
    GLASS LOSS OF RESISTANCE SYRINGE
    PAJUNKS STIMULONG TSUI-METHOD SET
    LOSS OF RESISTANCE SYRINGE
    POLYPLEX STIMULATING CATHETER SYSTEM
    EPILONG KIT FOR ANESTHESIOLOGY
    EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV
    CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET
    UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET
    MPS ACACIA NERVE BLOCK NEEDLE
    STINGRAY EPIDURAL CATHETER CONNECTOR
    MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS
    ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM
    STIMULONG PLUS CATHETER SET MODEL, VARIOUS
    PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
    PERIFIX CATHETER CONNECTOR
    B-SMART, MODEL B-01
    PERIFIX CATHETER CONNECTOR
    PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
    STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK
    AVID-NIT NERVE STIMULATION NEEDLES
    STIMUCATH CONTINUOUS NERVE BLOCK SET, PRODUCT NUMBER AB-05000
    PLEXOLONG SETS

    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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