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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: FNL FDA class 2

    Bed, Ac-Powered Adjustable Hospital

    General Hospital

    View full classification →

    The AC-Powered Adjustable Hospital Bed is an electrically powered hospital bed that allows motorized adjustment of head, foot, and height positions to optimize patient comfort and facilitate nursing care. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FNL, regulated under 21 CFR 880.5100 in the General Hospital specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    iBed Wireless with iBed Mobile
    IBED WIRELESS WITH IBED AWARENESS
    VAIL 1000 ENCLOSED BED
    MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED
    BENEFIT B3--- SERIES
    VOLKER HOSPITAL BED, MODEL K960
    SOMA 900 TRANSPORT BED
    VAIL 2000 ENCLOSED BED
    VAIL 3000 BED ENCLOSURE
    TOTALCARE
    SOMA SAFE ENCLOSURE
    NOVABED PATIENT TRANSFER SYSTEM
    ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002
    CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED
    2000 MODULAR THIRTY-NINE
    SSC MODEL 4000 SERIES
    JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL
    MC ACCLAIM Q6000 BED
    ELITE 3 LOW AIR LOSS BED
    VOLKER NURSING BED MODEL 2080E & 2090E
    STRYKER AGILITY INTENSIVE CARE BED
    BARIKARE PLUS
    AIRHYTHM HEALTHCARE BED
    S.S.C. MEDICAL MODEL 5000 SERIES BED
    MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES
    ADJUSTABLE BED
    GLENN BED
    STRYKER MPS ACUTE CARE BED
    COMFORTADE
    FLH1768M SERIES HOSPITAL BED
    BURKE BARIATRIC TREATMENT SYSTEM II
    FULL/SEMI ELECTRIC HOME CARE BED
    THE ADVANCE SERIES FROM HILL-ROM
    CRITICAL CARE HOSPITAL BED (ICU/CCU)
    EASY ACCESS BED
    SERIES 2000 ADJUSTABLE BED
    S.S.C. MEDICAL PRODUCTS HOME HEALTH CARE BED
    INVACARE EXTENDED CARE NURSING HOME BED
    THE INDEPENDENT CARE UNIT
    PREMISE SERIES BED
    PREMISE SERIES BED
    AIDE-A-PATIENT (NURSING HOME BED)
    CONSUMMATE AIR THERAPY BED
    MSI STANDARD BED MODELS L1098-84/L1098-74/L1085-74
    HOSPITAL BED CLOTHING CRADLE
    MAGNUM 800(TM) MANAGEMENT SYSTEM
    MSI 4000 SERIES BED
    MSI 3002 SERIES BED
    MSI 5000 SERIES BED
    MSI 2002 SERIES BED

    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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