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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: FNM FDA class 2

    Mattress, Air Flotation, Alternating Pressure

    General Hospital

    View full classification →

    The Alternating Pressure Air Flotation Mattress is a therapeutic mattress that cyclically inflates and deflates air cells to redistribute pressure beneath a patient, used to prevent and treat pressure ulcers in immobile patients. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FNM, regulated under 21 CFR 880.5550 in the General Hospital specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    PRESSURE GUARD SITE SELECT (A)
    MIGHTY AIR
    ZAK-2000
    PHYSIO/1000
    SIMPULSE
    SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
    BARIAIR
    KT AIR BED
    RID-DECUBE II
    ALTERNATING PRESSURE AIR FLOTATION MATTRESS
    MODIFIED PEDIKAIR
    REST MATTRESS
    CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM
    REST X SYSTEM
    EQUI-PISE 1000 MRS
    LUMEX AIR
    UNIT-MATT 5000 PRESSURE RELIEF SYSTEM
    9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS
    APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM
    9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS
    9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD
    AIR-MEDEX I
    PRESSUREGUARD: SELECTCARE
    SPR PLUS II OVERLAY SYSTEM (CL250/CL212
    AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM
    POWERED LOW AIR LOSS MATTRESS SYSTEM
    PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM
    AREMA II
    ALTACARE
    MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS
    THE AIRCEL SYSTEM
    PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
    CARDIO-SYSTEMS PRO-OP
    PRESSUREGUARD IV
    ALTADYNE
    PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500)
    AMERIMED AS110
    ERGOMAT 5000 SYSTEM
    ERGOMAT 8000 SYSTEM
    BAZOOKA SYSTEM
    THE LOTECON PERSONAL CARE SYSTEM
    PRESSUREGUARD IV
    TRIADYNE
    MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT
    MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS
    PEGASUS BIWAVE PLUS SYSTEM
    PARAGON PORTABLE
    LAKE STAGEZERO(TM) AIR FLOTATION BED
    DYNAMEDICS ASAR
    P/2000

    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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