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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: LIO FDA class 1

    Device, Specimen Collection

    Microbiology

    View full classification →

    A specimen collection device is a microbiological tool used to collect patient samples such as swabs, aspirates, or other specimens for subsequent laboratory analysis, supporting the diagnostic workup of infectious and other diseases. The device is FDA Class 1, the lowest risk category, requiring only general controls and 510(k) notification in this classification scenario. It carries product code LIO and is regulated under 21 CFR 866.2900 within the Microbiology specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ARX Liquid Amies Collection & Transport System
    PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
    TRANSPORT CULTURE MEDIUM DEVICE
    MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
    VIROCULT, MODEL MW950
    COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE
    BACTI-SWAB DRY
    NAT - NUCLEIC ACID TRANSPORT
    ENTERO-TEST HP, MODEL #102-01
    PAR-ONE
    PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF
    STP SYSTEM PVA WITH ZINC
    STP SYSTEM - SAF
    STP SYSTEM-PVA WITH MERCURY
    STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
    MID-STREAM COLLECTION SET-STERILE
    PINWORM EGG COLLECTOR
    PARA-PAK PLUS
    ZINC PVA
    APEX SPECIMEN BAG
    CYTOQUANT COMBINED TRANSPORT MEDIA
    TRANSYSTEM AMIES WITH CHARCOAL
    TRANSYSTEM LIQUID AMIES MEDIUM
    TRANSYSTEM LIQUID STUART MEDIUM
    TRANSYSTEM AMIES W/O CHARCOAL
    AFFIRM VP SAMPLE COLLECTION SET
    URINE CULTUR STABILIZATION TRANSPORT TUBE
    CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
    BACTI-SWAB(TM) NPG
    BACTI-SWAB(TM) II
    GASTRO-INTESTINAL ACCU-CULSHURE TM
    SAF FIXATIVE
    CHLAMYDIA ACCU-CULSHURE TM
    VIRAL ACCU-CULSHURE TM
    FLORA-STAT URINE TRANSPORT SYSTEM
    SPECIMEN CONTAINER
    ROMCHECK SPECIMEN COLLECTION KIT
    PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
    FTK FECAL TRANSPORT KIT
    NOVAPATH SPECIMEN COLLECTION KIT
    DIVERSI-KIT
    SNAP(R) ROTAVIRUS DIAGNOSTIC KIT
    PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT
    CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT
    FLUORTRAN - C(TM)
    NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
    MODIFIED PATHFINDER SPECIMEN COLLECTION KIT
    KULTSURE
    CULT-UR
    IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT

    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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