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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: JOW FDA class 2

    Sleeve, Limb, Compressible

    Cardiovascular

    View full classification →

    The Sleeve, Limb, Compressible is a cardiovascular device that applies intermittent pneumatic compression to the limbs through an inflatable sleeve, used to prevent deep vein thrombosis (DVT) and improve venous return in patients who are immobile or at risk for thromboembolic complications. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification prior to marketing. It carries product code JOW and is regulated under 21 CFR 870.5800, within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Venera 608 Deep Vein Thrombosis (DVT) Prevention System
    ARTAIRA Arterial Compression Device (AACD01)
    UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF
    Venowave VW5
    Therm-X (Home); Therm-X (AT)
    Nimbl (model PD08-N1)
    DVT Motion Pneumatic Compression Device
    Lymphedema Compression
    Dayspring
    ElastiMed SACS
    MedHealth DVT compression Devices MHH900S/MHH900E
    AeroDVx Arm System
    LEGACY® IPC
    Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
    Capiflo 5001
    AIROS 6P Sequential Compression Device
    AIROS 8P Sequential Compression Device
    medi pneumatic compression system (pcs)-genius (Model 652)
    VenAir, Sequential Compression System
    CIRCUL8 Connect DVT Prevention Device
    Amputee Garment for use with Lympha Press Optimal Plus
    Veinoflow SCD (Model: LBTK-M-I 5006)
    SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System
    Circul8 Pro
    Venen-trainer (Model: FM150, SFM90)
    Dayspring Lite
    CIRCUL8 Luxe DVT Prevention Device
    WoundExpress
    PlasmaWave
    Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
    Reprocessed Tri Pulse Compression Garment
    Dayspring
    DVT-PRO
    SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System
    DVT-4000S
    Movement and Compressions System (the MAC System)
    Ezlymph, Ezlymph M
    Overlapped Compression Therapy
    Flexitouch Plus System
    DVT-2600
    B&J DVT Calf/Thigh Garments, Models 801/830 Series
    B&J DVT Foot Garments, Models 820 Series
    VariLymph 12 pro
    ManaFlow
    B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System
    B&J DVT Compression Devices MHH800/MHH800SQ
    VenaOne
    Zeroveno
    Koya Ripple
    Aria System

    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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