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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: JSM FDA class 1

    Culture Media, Non-Propagating Transport

    Microbiology

    View full classification →

    Culture Media, Non-Propagating Transport is a microbiological laboratory reagent used to preserve and maintain clinical specimens during transport to a laboratory without allowing microbial growth, ensuring sample viability for subsequent testing. It is classified as FDA Class 1, meaning it poses the lowest risk and is subject only to general controls such as proper labeling and manufacturing standards. The product code is JSM, regulated under 21 CFR 866.2390, and falls within the Microbiology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    AllTest Viral Transport Medium
    UriSponge™
    Ensol EnTM Specimen Collection and Transport System
    OmniTrans Transport System
    Viral Transport Medium
    Avantik VTM
    Viral Transport Media (VTM)
    Copan Universal Transport Medium (UTM-RT) System
    Azer Scientific Universal Transport Medium
    ARX Viral Transport Media Collection and Transport System
    KaiBiLi Extended ViralTrans
    MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
    BioSci™ Disposable Virus Sampling Tubes
    Copan FecalSwab Collection, Transport and Preservation System
    Disposable Urine Collection Tube
    iClean Viral Transport System (VTM-RT kit)
    Disposable Sampler Viral Transport Media
    BioTeke Sterile Disposable Virus Sampling Kit
    Cultura Collection and Transport System
    UriSwab-Urine Collection, Transport and Preservation System
    Greiner Vacuette Urine Count and Culture, Mannitol tube
    Puritan Fecal Opti-Swab Collection and Transport System
    Puritan Opti-Tranz Cary-Blair Collection and Transport System
    Para-Fix C&S Medium
    COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
    MCC Para-Fix CARY BLAIR MEDIUM
    Puritan OptiTranz Liquid Stuart Collection and Transport System
    TRANSPORT CULTURE MEDIUM DEVICE
    COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM
    MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
    URINE MONOVETTE BORIC ACID
    BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS
    COPAN VIRAL TRANSYSTEM
    CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
    SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
    CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION)
    A.C.T. I
    A.C.T. III
    A.C.T. II
    A.C.T. IV
    CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA
    MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
    10B ARGININE BROTH
    CVM TRANSPORT
    COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM
    COPAN VENTURI TRANSYSTEM STUARTS MEDIUM
    COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL
    COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM
    COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL
    COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM

    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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