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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: KMK FDA class 1

    Device, Intravascular Catheter Securement

    General Hospital

    View full classification →

    An Intravascular Catheter Securement Device is used to stabilize and secure indwelling intravascular catheters at the insertion site, reducing catheter movement, dislodgement, and related complications such as phlebitis and catheter-associated infections. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission required. The product code is KMK and it is regulated under 21 CFR 880.5210 in the General Hospital specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
    A P HARNESS
    MULTI-PURPOSE MEDICAL TUBE HOLDER
    SECURE-SITE
    STATLOCK CV
    IV START KITS
    IMMOBILE STERILE AND IMMOBILE A/C STERILE
    IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE
    CONMED VENI-GARD I.V. DRESSING
    K-LOK CATHETER SECUREMENT DEVICE MODIFICATION
    CENTERMARK SECURING WINGS
    SECURODRIP (TM) I.V. ARMBOARD
    DUODERM TRANSPARENT HYDROCOLLOID DRESSING
    IV COMFORT PAD
    IAB ANCHOR
    K-LOK CATHETER SECUREMENT DEVICE
    KWIK BOARD
    I.V. PRO
    ILS(TM) - INVASIVE LINE SEPARATOR
    DERMASSIST TRANSPARENT SITE DRESSING
    TRACE MODEL# 840, 841,842 & 845 ARM BOARD
    TUBE, LEAD, AND CORD HOLDER NO. 102
    FOLEY CATHETER TUBE HOLDER NO. 101
    RESTRAINT, PROTECTIVE N0. 103
    DESERET POSITIONAL SUTURE WING
    SECURODRIP
    IV HOUSE
    INTRAVASCULAR CATHETER SECURMENT DEVICE
    PICC-FIX
    COMFOR-BOARD
    GENNY DENNY IV SHIELD
    BABY BOARDS IV SUPPORT ASSEMBLY
    VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE
    VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE
    JOHNSON & JOHNSON TUBE SECUREMENT DEVICE
    DALE I.V. IDENTIFIER; PRODUCT #1125
    DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220
    TIMLEINE(TM) VENIPUNCTURE SYSTEM
    E-Z HOLD - #4060
    IV BAND (INTRAVENOUS CATHETER ASSESORY)
    HOLD-IT FRAMED ADHESIVE FILM
    I.V. DRESSING
    SAFTI-BRACELET
    SECU-TAPE UNIVERSAL FLEXIBLE MEDICAL CLAMPS
    TRENDS LANCET
    VENI-SHIELD
    INTRAVASCULAR CATHETER SECUREMENT DEV
    FPP IV SECURE
    I.V. FILTER HOLDER
    FREHAN INC. I.V. FILTER HOLDER

    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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