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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: FPP FDA class 1

    Stretcher, Hand-Carried

    General Hospital

    View full classification →

    The Hand-Carried Stretcher is a non-wheeled litter or carry stretcher used to manually transport patients in emergency or clinical environments where wheeled transport is not feasible. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FPP, regulated under 21 CFR 880.6900 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.

    510(k) Clearances

    39 matches
    K Number
    Device Name
    BABY POD
    MED-EVAC-4 MEDICAL EVACUATION STRETCHER
    STRYKER MODEL 6110 EMERGENCY/POLE STRETCHER
    EVACU-SLED
    RESTRAINING STRETCHER
    U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER
    FERNO-WASHINGTON BASKET STRETCHER, MODEL 71-W
    LIFE LITE EMERGENCY STRETCHER
    BASKET LITTER CARRIER
    GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED
    EVACU SLED
    HAND CARRIED STRETCHER
    RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM
    WEEVAC TC HAND CARRIED RESCUE STRETCHER
    MANHANDLER
    HAND-CARRIED STRETCHERS
    LITTER, NONRIDGID, POLELESS, NYLON STRETCHER
    HAND-CARRIED STRETCHERS/BREAK AWAY FLAT
    WEEVAC 1 PORTABLE RESCUE STRETCHER
    LITTER, FOLDING RIGID POLE, DECONTAMINABLE
    WEEVAC 6 INFANT EVACUATION STRETCHER
    HARE EMERGENCY STRETCHER
    HARE EMERGENCY STRETCHER WITH WHEELS
    SKED FLOTATION SYSTEM
    SKED STRETCHER
    THE SMITHCOT
    NET STRETCHER PAD (TM)
    FOLDING LITTER SUPPORT, NSN6530-00-660-0034
    BACK REST, LITTER, NONADJUSTABLE
    BACK REST, LITTER, NON-ADJUSTABLE
    IMMOBILIZING VACUUM MATRESS (IVM)
    DONWAY LIFTING FRAME
    VACUUM STRETCHER IMMOBILIZER
    INFANT EVALUATION CARRIER
    MATELAS COQUILLE LATTREDE TASSIGNY
    ARALUEN HEAD SHIELD
    ARALUEN SKY GRAB BRIDLE
    THE ARALUEN CARRIER
    MEDISHIELD JORDON LIFTING FRAME

    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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