BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Bio Arterial Deluxe (IC-BAP-DX)

    K Number: K250974 · Decision Dec 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    15
    Review Days
    256

    Basic Information

    Device Name
    Bio Arterial Deluxe (IC-BAP-DX)
    K Number
    K250974
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio Compression Systems, Inc.
    Date Received
    March 31, 2025
    Decision Date
    December 12, 2025
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Bio Compression Systems, Inc.

    K Number Device Name
    K213533 Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
    K210417 Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
    K180248 VascuEase IC-1200-WH
    K171793 Sequential Circulator SC-2004FC-OC
    K150953 Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
    K142640 Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator
    K131306 IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE
    K131327 BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
    K122112 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM
    K072666 BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
    Search all 15 clearances from Bio Compression Systems, Inc. →