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: MVA FDA class 2

    Orthosis, Cranial

    Neurology

    View full classification →

    A Cranial Orthosis is a custom or prefabricated external head device used to reshape the skull of infants with positional plagiocephaly (flat head syndrome) or craniosynostosis by applying gentle, corrective pressure to redirect skull growth during the period of rapid cranial development. It is FDA Class 2, requiring 510(k) clearance, with product code MVA under 21 CFR 882.5970 in the Neurology specialty. The device is not an implant and is not life-sustaining.

    510(k) Clearances

    43 matches
    K Number
    Device Name
    Talee, Talee PostOp
    Talee, Talee PostOp
    STARband 3D
    Talee, Talee PostOP
    Hanger Cranial Band 3D
    MyCRO Band
    SnugKap
    MyCRO Band
    KidCap
    STARBAND, STARLIGHT
    STARBAND AND STARLIGHT
    P-POD
    BOSTON BAND
    CRANIAL REMOLDING ORTHOSIS
    AOI CRANIAL HELMET
    MICHIGAN CRANIAL RESHAPING ORTHOSIS
    CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)
    CRANIAL SOLUTION ORTHOSIS
    O&P BIVALVE CRANIAL MOLDING HELMET
    DOC BAND-POSTOP
    CRANIAL HELMET
    COPC BAND
    DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS
    PROVIDENCE MOLDING HELMET
    LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET
    CRANIAL SYMMETRY SYSTEM
    O&P CRANICAL MOLDING HELMET
    STATIC CRANIOPLASTY ORTHOSIS
    ORTHOSIS HELMET MOLDING
    BECKER BAND CRANIAL REMOLDING ORTHOSIS
    PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS
    MOLDED CRANIAL HELMET
    LERMAN & SON CRANIAL ORTHOSIS HELMET
    CRANIAL HELMET
    RHS HELMET
    BALLERT CRANIAL MOLDING HELMET
    CLARREN HELMET
    DANMAR PRODUCTS MICHIGAN CRANIAL HELMET
    CRANIAL MOLDING ORTHOSIS
    HANGER CRANIAL BAND
    CRANIOCAP
    OPI BAND
    DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND

    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

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump