BEUDAMED
    Product Code: QAQ FDA class 2 21 CFR 870.2210

    Adjunctive Predictive Cardiovascular Indicator

    Cardiovascular

    The Adjunctive Predictive Cardiovascular Indicator is a prescription software device that uses algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events, intended for adjunctive use alongside other physical vital sign parameters and patient information, and not designed to independently direct therapy. It is classified as a Class 2 device under regulation 870.2210, requiring 510(k) premarket notification, and falls within the Cardiovascular (CV) medical specialty. The product code is QAQ. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    5
    FEI Numbers
    12
    Registration Numbers
    12
    Unique Applicants
    2
    Years Active
    7

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    Basic Information

    Product Code
    QAQ
    Device Class
    FDA class 2
    Regulation Number
    870.2210
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 5 510(k) clearances via K numbers.

    K Number Device Name
    K242518 Hypertension Prediction Index (HePI) Algorithm
    K230057 Acumen Hypotension Prediction Index (HPI) Algorithm
    K203224 Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
    K183646 Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure
    DEN160044 Acumen Hypotension Prediction Index (HPI) Feature Software

    FEI Numbers

    This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.