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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: ETN FDA class 2

    Stimulator, Nerve

    Ear, Nose, Throat

    View full classification →

    The nerve stimulator is a device used in ENT procedures to identify and test the integrity of peripheral nerves, such as the facial nerve, during surgery to reduce the risk of inadvertent nerve damage. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is ETN, regulated under 21 CFR 874.1820 in the Ear, Nose, Throat specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
    Bioscope Neuromonitor Device
    EARP Nerve Cuff Electrode
    Disposable Laryngeal Electrodes
    NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
    EARP Nerve Cuff Electrode
    NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
    C2 Xplore
    Mapping Suction Probe
    NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
    Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
    StimSite
    FREMAP ELECTRODE
    C2 NerveMonitor System
    Checkpoint, Checkpoint Head & Neck
    STIM PROBE
    ES2 NEUROMONITORING ACCESSORY INSTRUMENTS
    INVOTEC LARYNGEAL ELECTRODE
    NONDISPOSABLE STIMULATING INSTRUMENTS
    LARYNGEAL ELECTRODE
    NEXT GEN EMG ENDOTRACHEAL TUBE
    NUVASIVE NVJJB SYSTEM
    XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES
    NUVASIVE NVM5 SYSTEM
    STIMULATION/DISSECTION INSTRUMENTS
    SEASPINE MONOPOLAR PROBE SYSYEM
    NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
    DISPOSABLE STIMULATING ELECTRODE
    RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT
    NEURO CHECK DEVICE WITH IO-FLEX WIRE
    DRYTOUCH SUCTION STIMULATOR PROBE
    SURGICAL STIMULATORS
    PAIRED HYDROGEL ELECTRODE
    CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,
    NEUROVISION SE (NERVEANA)
    NEURALMAS
    LARYNGEAL SURFACE ELECTRODE
    INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656
    CHECKPOINT
    BAXANO NEURO CHECK DEVICE
    NEUROSIGN AVALANCHE MOTOR NERVE MONITOR
    STIMULUS/DISSECTION INSTRUMENTS
    BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25
    RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
    NEUROSIGN LARYNGEAL ELECTRODES
    HILGER DUAL-STIM NERVE STIMULATOR
    STIMULATING BUR GUARD
    XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
    CHECKPOINT WITH ACCUSTIM TECHNOLOGY
    NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800

    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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