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: JTW FDA class 1

    System, Transport, Aerobic

    Microbiology

    View full classification →

    System, Transport, Aerobic is a specimen transport system designed to maintain the viability of aerobic microorganisms in clinical specimens from the time of collection until laboratory processing, preserving organism integrity for subsequent culture and identification. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JTW, regulated under 21 CFR 866.2900, and falls within the Microbiology medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    43 matches
    K Number
    Device Name
    COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
    COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM
    GEN-PROBE APTIMA COMBO 2 ASSAY
    URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
    COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM
    SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)
    CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)
    CULTURESWAB TRANSPORT SYSTEM
    P AND T MEDIUM
    FDL, INC.'S TRANSPORT SYSTEM
    MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE
    GONOSTAT FEMALE SPECIMEN COLLECTION & TRANSPORT
    GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT
    URINE TRANSPORT KIT
    GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK
    CELL-MATICS VIRAL TRANSPORT PACK
    BAKTERIETTE-VI-PAK
    PRESERV TRANSPORT & CULTURE PACK
    PRESERV CARY BLAIR TRANSPORT PACK
    PRESERV BUFFERED GLYCEROL SALINE
    GONORRHEA TRANSETTE 1 & 3
    CVT VIRAL TRANSPORTS
    HERPES TRANSETTE
    GC TTANSPORT SYSTEM
    JEMBEC TRANSPORT SYSTEM
    MINI-TIP CULTURETTE
    TRANSETTE SYSTEM/COLLECTION & TRANSP
    CULSWAB CAT.#978 & 979
    PDC 304 DOUBLE SWAB CULTURE COLLECTION
    PDC 104 SINGLE SWAB CULTURE COLLECTION
    URINE CULTURE KIT
    CHAMBER, AEROBIC
    CULTURE COLLEC. TRANS. SYS., SINGLE WET
    CULTURE COLLEC. TRANS. SYS., DOUBLE DRY
    CULTURE COLLEC. TRANS. SYS., SINGLE DRY
    CULTURE COLLEC. TRANS. SYS., SINGLE WET
    CULTURE COLLEC. TRANS. SYS., DOUBLE WET
    CULTURE COLLEC. TRANS. SYS., DOUBLE WET
    EPTONE BACK-UP BROTH, VACUTAINER
    PEDIATRIC BLOOD CULTURE BOTTLES
    BOTTLE, BLOOD CULTURE, BI-PHASIC
    BOTTLE, BLOOD CULTURE, SCHAEDLER
    CULTURE TUBE, (VACUTAINER)

    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