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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: KLW FDA class 2

    Masker, Tinnitus

    Ear, Nose, Throat

    View full classification →

    A Tinnitus Masker is an ear, nose, and throat device worn in or around the ear that generates a broad-spectrum or narrowband sound to mask or reduce the perception of tinnitus (ringing or noise in the ears), providing relief for affected patients. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KLW and the applicable regulation is 21 CFR 874.3400 in the Ear, Nose, and Throat specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Peace N Quiet (0.7.0)
    Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)
    Tinnitogram Signal Generator
    SilentCloud
    Multiflex Tinnitus Technology
    Tinnitus Sound Generator Module
    Tinnitus Sound Generator Module
    Tinnitus Sound Generator Module
    audifon Tinnitus-Module
    TinniLogic Mobile Tinnitus Management Device
    Sound Options Tinnitus Treatment
    HyperSound Tinnitus Module
    Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System
    REVE134
    Serenity
    Tinnitus Sound Generator Module
    SoundCure Serenade Tinnitus Treatment System
    LEVO TINNITUS MASKING SOFTWARE DEVICE
    SOLACE SOUND GENERATORS
    TINNITUS SOUNDSUPPORT
    WAVE 2G, SOUL
    AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT
    AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
    UNITRON TINNITUS MASKER FEATURE
    PHONAK TINNITUS BALANCE
    MULTIFLEX TINNITUS TECHNOLOGY
    TINNITUS THERAPY SYSTEM ANM T30 CR
    SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM
    IE-ZEN (IN CLEAR SERIES HEARING AID)
    TINNITUS SOUND GENERATOR MODULE
    EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE
    SWITCH TRT
    JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT
    ZEN PROGRAM (MIND 440 HEARING AID)
    TINNITUS SOUND GENERATOR MODULE
    CUSTOMIZED SOUND THERAPY (CST)
    THE INHIBITOR, MODEL 001
    TRANQUIL TRI-BTE
    TINNITUS PHASE-OUT
    NEUROMONICS TINNITUS TREATMENT
    REFUGE SOUND GENERATOR
    QUIESCENCE
    CRESCENT TINNITUS RETAINING SOUND GENERATOR
    TINNITUS RX
    ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)
    ULTRAQUIET
    TST - SUPPRESSOR MODEL #1000
    HISONIC-TRD TINNITUS RELIEF DEVICE
    CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
    CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)

    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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