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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: BSP FDA class 2

    Needle, Conduction, Anesthetic (W/Wo Introducer)

    Anesthesiology

    View full classification →

    The Needle, Conduction, Anesthetic (W/Wo Introducer) is a needle used to inject local anesthetic agents near nerves or into specific anatomical spaces to achieve regional anesthesia, optionally supplied with an introducer to guide placement. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BSP, regulated under 21 CFR 868.5150 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SonoMSK
    SonoPlex STIM; SonoPlex II
    SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture
    SonoTAP and SonoTAP II
    SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
    SonoBlock; SonoBlock II
    Reach Needle
    Medispine - Spinal Needle, Glospine - Spinal Needle
    BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle
    BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
    RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
    DiscCath Needle Set
    BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
    Stimuplex Onvision System
    Ancora Nerve Block Catheter Set
    Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)
    Dr J Spinal and Epidural Needles
    Portex NRFit Epidural Needles
    Pakter Curved Needle Set
    Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters
    GRAFTSITE
    StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle
    IMD's Lumbar Puncture Needle
    EchoGlo Needle
    Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles
    Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford
    NerveGuard NRFit, NerveGuard LUER
    Pinpoint GT Needles
    Entellus Medical Reinforced Anesthesia Needle
    Tuohy NRFit
    SPROTTE SPECIAL NRFit
    SPROTTE NRFit, Quincke NRFit
    SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles
    SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
    Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
    Remington Medical Inc. Tuohy Epidural Needles
    UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle
    UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE
    PERICAN ULTRA
    ANESTHESIA CONDUCTION NEEDLES
    SONIXGPS
    ANESTHESIA CONDUCTION NEEDLES
    CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE
    SONO TAP, TUOHY SONO
    PENCAN SPINAL NEEDLE
    SONO-SERIES CORNERSTONE TECHNIQUE
    MEDLINE EPIDURAL AND SPINAL NEEDLES
    FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
    CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680
    FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE

    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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