BEUDAMED
    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: KME FDA class 1

    Bedding, Disposable, Medical

    General Hospital

    View full classification →

    Disposable Medical Bedding refers to single-use bed linens, pads, or protective covers used in healthcare settings to maintain patient hygiene, absorb fluids, and reduce the risk of cross-contamination between patients. It is classified as FDA Class 1, indicating low risk subject to general controls without premarket clearance required. The product code is KME and it falls under 21 CFR 880.6060 in the General Hospital specialty. This device is GMP exempt.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    READY-HEAT BLANKET
    OREX MEDICAL BEDDING
    DISPOSE-A-SHEET
    DOCTOR DOWN --RESCUE WRAP
    AMERICAN BURN SHEET
    FOIL BABY BUNTING
    CHEM-SLEEVE B
    MEDI GUARD PILLOWCASE
    MEDI GUARD UNDERPAD
    MEDI GUARD SHEETS/UNDERLAYS
    MEDI GUARD DRAPES
    BIO-GUARD SHAVE PREP TRAY
    RECEIVING BLANKET
    TRAUMA SLEEVE
    CHEM-SLEEVE
    FLUID SOAKERSHIELD
    MATTRESS COVER FOR MEDICAL PURPOSES
    MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE
    DEVON DISPOSABLE HEAD POSITIONER COVER
    BED SHEET, PILLOW CASE
    HEADREST, PATIENT COMFORT
    DRY COMFORT DISPOSABLE UNDERPAD
    DRIPRIDE DISPOSABLE UNDERPAD
    DRIPRIDE DISPOSABLE UNDERPADS
    PAD, BED LINEN PROTECTIVE
    DEPEND UNDERPAD
    THERMAPAD
    KIMLON DISPOSABLE BLANKET
    SINGLE-USE PATIENT UNDERPAD
    REFLECTIVE BLANKET
    ALPHA CHUCK
    ATTENDS DISPOS. UNDERPAD
    MEDICAL, DISPOSABLE BEDDING
    PAD, PRE-OPERATIVE PREPARATION
    SHAVE PREP TRAY
    SHAVE PREP KITS
    WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT
    DISPOSABLE PATIENT BLANKET
    MOLINEA UNDERPADS
    PILLOW W/STAPHCHEK TICKING
    DISPOSABLE PILLOW
    DRAW SHEET, ANTI-MICROBIAL
    PILLOW COVER, ANTI-MICROBIAL
    SUPER DONUT
    BARRIER BURN SHEET
    3M THINSULATE DISPOSABLE HOSPITAL BED
    NON-ABSORBENT TOWELS
    PATIENT UNDERPAD
    DISPOSABLE PILLOW
    DISPOSABLE UNDERPADS

    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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