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: KRD FDA class 2

    Device, Vascular, For Promoting Embolization

    Cardiovascular

    View full classification →

    This device is a vascular device used to promote embolization, which involves intentionally occluding blood vessels to treat conditions such as arteriovenous malformations, aneurysms, tumor vascularity, or hemorrhage through interventional radiology or vascular surgery. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRD, regulated under 21 CFR 870.3300 within the Cardiovascular specialty. This device is designated as an implant, as it is placed within the vascular system.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HARBOR Occlusion Device
    Prestige Coil System (Prestige Packing Line Extension)
    Embosphere Microspheres
    Nitinol Enhanced Device (NED)
    Ruby XL System
    Embozene Color-Advanced Microspheres
    TEMBO Embolic System
    ONCOZENE Microspheres
    OBSIDIO™ Conformable Embolic
    Sunsphere
    Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)
    Easi-Vue® embolic microspheres System
    UniPearls® Embolic Microspheres
    EMBOLD™ Soft Detachable Coil System
    AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
    Easi-Vue embolic microspheres System
    GEM
    LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)
    EMBOLD Fibered Detachable Coil System
    Prestige Coil System
    Solus Gold Embolization Device
    Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS
    Merit Siege Vascular Plug
    HRSpheres Narrow-Size Embolic Microspheres
    Concerto Versa, Detachable Coil
    LOBO Vascular Occlusion System (model LOBO-5)
    AZUR Vascular Plug
    EMBA Hourglass Peripheral Embolization Device (PED)
    The Caterpillar and Caterpillar Micro Arterial Embolization Devices
    Torpedo Gelatin Foam
    Okami Medical LOBO Vascular Occlusion System
    EmboCube Embolization Gelatin
    Torpedo Gelatin Foam
    IMPEDE-FX Embolization Plug
    Dr. Amplatz Micro Plug
    EmboCube Embolization Gelatin
    Embosphere Microspheres
    IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm
    Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
    Gel-Bead
    QuadraSphere Microspheres
    EMBA Hourglass Peripheral Embolization Device
    AZUR CX Detachable 18 Peripheral Coil System
    LC Bead LUMI
    Hilal Embolization MicroCoils
    Nester Embolization Coils, Tornado Embolization Coils
    Bead Block
    HydroPearl Microspheres, HydroPearl Microspheres
    MReye Flipper Detachable Embolization Coil and Delivery System
    MReye Embolization Coils

    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