BEUDAMED
    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: ETY FDA class 2

    Tester, Auditory Impedance

    Ear, Nose, Throat

    View full classification →

    The auditory impedance tester is a diagnostic device that measures the acoustic impedance or admittance of the middle ear system to assess tympanic membrane mobility and middle ear function, used in the diagnosis of conditions such as otitis media and ossicular chain disorders. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is ETY, regulated under 21 CFR 874.1090 in the Ear, Nose, Throat specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Hearing Healthcare Pro
    Hearing Healthcare Pro
    touchTymp
    Madsen Zodiac
    AT235
    GSI TympStar Pro Middle Ear Analyzer
    INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE
    TITAN
    TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE
    AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER
    EARCHECK ACOUSTIC REFLECTOMETER
    OTOFLEX 100 TYE 1012
    AMPLAID A756 SCREENING ADMITTANCE METER
    AUDIOTRAVELLER, MODEL AA222
    GSI 2000 MIDDLE EAR ANALYZER
    INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER
    PASCAL MEDICAL AB MENIETT 20
    AMPLAID A724 AND A728
    INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
    INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER
    INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
    AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER
    AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
    AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
    AMPLAID AM50
    EARCHECK
    EARCHECK PRO
    RACE CAR TYMPANOMETER
    MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION
    INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26
    INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER
    AE-207D TYMPANOMETER
    THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S
    HANDTYMP
    AUTOMATIC TYMPANOMETER
    GSI 38 AUTO TYMP
    AUTOMATIC IMPEDANCE METER AE-205
    AE-206 TYMPNOMWRWE(R) AUDIOMETER
    ZODIAC 901 MIDDLE-EAR ANALYZER
    MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
    GSI 37 AUTO TYMP
    MIDDLE EAR ANALYZER, MODEL AE-803
    IMMITTANCE METER, MODEL AE-105D/S
    AMPLAID 770 ADMITTANCE METER
    AE-105D DIAGNOSTIC TYMPANOMETER
    MODEL 210 IMPEDANCE SYSTEM
    IMPEDANCE ANALYZER MODELS MD-2, MD-P
    HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.
    STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT
    AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER

    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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