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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: FRF FDA class 2

    Cleaner, Air, Medical Recirculating

    General Hospital

    View full classification →

    A medical recirculating air cleaner is a device used in healthcare settings to filter and recirculate room air, removing particulate matter and potentially infectious aerosols. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is FRF, regulated under 21 CFR 880.5045, within the General Hospital medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    CerroZone Mini
    Airdog X8 Air Purifier (KJ800F-X8)
    MA-40, MA-112
    RIA Safeguard
    Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
    Qorda QD1
    CerroZone Mobile
    Novaerus NV1050
    AIRSONETT AIR-4
    HEPAIRX VENTILATING AIR PURIFIER
    AIRSONNETT AIRSHOWER AIR 3
    AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000
    PLASMAIR, MODEL T2006
    MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
    ADVANCED AIR PURIFICATION SYSTEM; HEPA AIR CLEANING SYSTEM
    DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A
    DEFENDER ROOM AIR CLEANER, MODEL RAC-3000A
    HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C
    BREATHE EASY, MODELS AD AND CD
    MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP
    HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588
    SLANT/FIN HEPA CLEAR
    FRIEDRICH ELECTRONIC AIR CLEANER
    AIR CLEANERS WITH HEPA FILTRATION
    BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER
    BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550
    NORELCO CLEAN AIR SYSTEM
    NORELCO CLEAN AIR SYSTEM CAS950
    NORELCO CLEAN AIR SYSTEM CAS900
    PA300
    NORELCO CLEAN AIR SYSTEM MODEL CAM665
    HEPA AIR CLEANER
    POLLENEX HEPA AIR CLEANERS
    HOLMES AIR PURIFIER MODELS HAP-240 & HAP-300
    HEPA 2500 AIR CLEANER
    HUNTER AIR CLEANERS MODEL NOS. 30100/30250/30300
    AIR-ELECTRONIC AIR CLEANER (FILTER)
    ENVIRACAIRE MODEL EV-1
    HEPACRON PUREAIR-ZONE SYSTEM
    HYGIENIC AIR PURIFYING DEVICE
    INSTAPURE
    MODEL BION 2/TYPE 90 ROOM IONIZER
    MODEL BION 1/TYPE 1084T CAR IONIZER
    LABMASTER & CRSI 600
    HAYFEVER HELMET
    BREATHING ZONE
    AIR ALIVE
    ULTIMATE-AIRE
    DOTRICH ELECTRONIC AIR CLEANER #C500AM
    AIR PURIFIER

    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.

    Popular Product Codes

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