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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: HFW FDA class 2

    Clamp, Umbilical

    Obstetrics/Gynecology

    View full classification →

    The Umbilical Clamp is a device used immediately after birth to clamp the umbilical cord, cutting off blood flow between the infant and the placenta before the cord is cut. It is classified as FDA Class 2 (moderate risk) within the Obstetrics/Gynecology specialty and is subject to general controls. The product code is HFW, regulated under 21 CFR 884.4530. No implant or life-sustaining flags apply.

    510(k) Clearances

    36 matches
    K Number
    Device Name
    JOEY CLAMP OPENING TOOL
    KAEN YIH UMBILICAL CORD CLAMP
    SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
    BUSSE UMBILICAL CORD CLAMP CUTTER
    DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
    KOALA CLAMP, KOALA CLAMP AND CUTTER
    KOALA CLAMP
    POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385
    UMBICUT
    UMBILICAL CORD CLAMP
    SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540
    'ECURLINE UMBILICAL CORD CLAMP #3500
    HARWILL MEDICAL U-KLIP UMBILICAL CLAMP
    HOSPITAL'S CLAMP
    EZ-CIRC
    QFC UMBILICAL CLAMP
    UMBILICAL CLAMP AND CUTTER
    BIRTH THEFT INFANT IDENTIFICATION AND PROTECTION UMBILICAL CORD CLAMP
    KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR
    SAVE-T-BREATH AMBILICAL CORD CLAMP
    AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER
    LUNEAU UMBILICAL CORD CLAMP
    CORDGUARD BLOOD COLLECTION DEVICE
    UMBILICAL CLAMP
    LABOR DELIVERY TRAY
    WOMEN AND INFANT'S DELIVERY PACK
    AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEVERING DEVIC
    UMBILICAL CORD CLAMP AND CUTTER
    #556 DISPOSABLE UMBILICAL CORD CLAMP (2)
    COMPRESSION FORCEPS
    UMBILICAL CORD CLAMP
    SCMT UMBILICAL CLAMP
    DOLPHIN UMBILICAL CORD CLAMP
    SCHULMAN DOUBLE UMBILICAL CORD CLAMP NO. 1000
    CLAMP-N-CUT
    UMBILICAL CORD CLAMP

    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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