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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: OBP FDA class 2

    Transcranial Magnetic Stimulator

    Neurology

    View full classification →

    The Transcranial Magnetic Stimulator (product code OBP) is a neurological treatment device that delivers brief duration, pulsed magnetic fields to induce electrical currents in spatially discrete regions of the cerebral cortex, specifically for the treatment of major depressive disorder (MDD). The device generates rapidly alternating magnetic fields applied non-invasively to the patient's scalp, targeting cortical areas involved in mood regulation. It is FDA Class 2 under regulation 882.5805 in the Neurology specialty, requiring 510(k) clearance and adherence to general and special controls. It carries no implant or life-sustaining flags.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Ampa One System (AMPA-001)
    Ultimate rTMS
    Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)
    Ampa One System (AMPA-001)
    Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)
    Deep TMS System
    Apollo TMS Therapy System
    NeuroStar Advanced Therapy System (All previously cleared models)
    ZapStim Controller Application (Z1023)
    NQ TMS for MDD (NQv1-MU-01)
    NeuroStar Advanced Therapy System (Version 3.8)
    Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro
    Ultimate rTMS; Yingchi rTMS
    NeuroStar Advanced Therapy System (Version 3.7)
    Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
    Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
    Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
    BrainsWay Deep TMS System
    NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health
    NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
    ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
    BTL-995-rTMS
    NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
    ALTMS Magnetic Stimulation Therapy System
    Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
    Deep Transcranial Magnetic Stimulation (DTMS) System
    Brainsway Deep TMS System
    NeuroStar Advanced Therapy
    HORIZON TMS Therapy System with Navigation
    Nexstim Navigated Brain Therapy (NBT) System 2
    HORIZON TMS Therapy System
    Mag Vita TMS Therapy System w/Theta Burst Stimulation
    HORIZON TMS Therapy System
    Apollo TMS Therapy System
    Brainsway Deep (DTMS) System
    Neurosoft TMS (also CloudTMS)
    Nexstim Navigated Brain Therapy (NBT) System 2
    MagVita TMS Therapy w/MagPro R20
    HORIZON Therapy System
    MagVita TMS Therapy System
    MagVita TMS Therapy System
    MagVita TMS Therapy - w/MagPro R20
    Rapid2 Therapy System
    Neurosoft TMS
    NeuroStar TMS Therapy System
    NeuroStar TMS Therapy System
    MagVita TMS Therapy System
    Rapid Therapy System
    NEUROSTAR TMS THERAPY SYSTEM
    NEUROSTAR TMS THERAPY SYSTEM

    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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