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

    CardioVision

    K Number: K251293 · Decision Nov 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    210

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CardioVision
    K Number
    K251293
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Icardio.Ai
    Date Received
    April 25, 2025
    Decision Date
    November 21, 2025
    Product Code
    QUO
    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
    QUO Adjunctive Heart Failure Status Indicator

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QUO), ordered by most recent decision date.

    EchoGo Heart Failure (2.0)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vivio® LVEDP System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EchoGo Heart Failure

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Icardio.Ai

    K Number Device Name
    K241430 EchoMeasure