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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: IOQ FDA class 2

    Bed, Flotation Therapy, Powered

    Physical Medicine

    View full classification →

    A Powered Flotation Therapy Bed is an electrically powered therapeutic mattress system used in Physical Medicine that uses dynamic air or fluid redistribution to continuously vary pressure beneath the patient, designed to prevent and treat pressure ulcers and improve patient comfort in long-term care or post-surgical settings. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IOQ, regulated under 21 CFR 890.5170, within the Physical Medicine medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Hill-Rom Wireless Connectivity Module
    TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2
    NURSE'S AID PATIENT ROTATION SYSTEM
    HYDROTEC LOW AIR LOSS THERAPY BED
    AIRTEC2 LOW AIR LOSS THERAPY BED
    TOTALCARE., MODULAR THERAPY SYSTEM (MTS)
    SILKAIR LOW AIRLOSS THERAPY
    FLEXICAIR EXLIPSE PLUS
    TOTAL CONTACT SEAT RIPPLE SYSTEM
    FLEXICAIR EXLIPSE
    DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE
    CLENSICAIR LOW AIRLOSS HYDROTHERAPY
    I-5000
    THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM
    PRISM
    ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE
    MICROAIR PUP
    MICROAIR TURN-Q
    AKROTECH 4000
    RESTCUE CC
    ORTHODERM CONVERTIBLE II
    HAZEL II
    FLEXICAIR LOW AIRLOSS THERAPY UNIT
    B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT
    TURBO
    MICROAIR 3500
    CLA-1400 SYSTEM
    HAZEL
    TASSI MK3 (TURNAIR)
    COMFORT-AIRE
    BIO MEDX AIR FLOTATION SYSTEM
    STAGE ZERO AIR FLOTATION BED
    STAGE III
    MARK IV FLOATATION THERAPY BED
    PULMONAIR 40 PATIENT MANAGEMENT SYSTEM
    SYSTEM 2500 MEDICAL WATERBED
    ORTHODERM CONVERTIBLE
    M.F.S. LOW AIR LOSS PULSATING BED
    AEROMAT MRS-1000
    FLUIDIZED AIR BED
    SYSTEM 3000 FLUIDIZED AIR BED
    ADD-ON TO CRITICAL PATIENT CARE BED
    PEDIATRIC HOSPITAL BED
    SMI 3000 AIRBED
    ULTRAFLOTATION BED
    AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS
    DERMGARD SYSTEM 800 AND 900
    MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE
    DECUB-I-CON 800 AND 900 SYSTEM
    SCHELL C.A.P.P. BED MODEL NRS. 1268 + 1269

    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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