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

    Acumen Hypotension Prediction Index (HPI) Feature Software

    K Number: DEN160044 · Decision Mar 16, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    4
    Applicant Total
    136
    Review Days
    536

    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
    Acumen Hypotension Prediction Index (HPI) Feature Software
    K Number
    DEN160044
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    870.2210
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Applicant
    Edwards Lifesciences, LLC
    Date Received
    September 26, 2016
    Decision Date
    March 16, 2018
    Product Code
    QAQ
    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
    QAQ Adjunctive Predictive Cardiovascular Indicator

    Similar 510(k) Clearances

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

    Hypertension Prediction Index (HePI) Algorithm

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Acumen Hypotension Prediction Index (HPI) Algorithm

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure

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

    Other Clearances by Edwards Lifesciences, LLC

    K Number Device Name
    K251326 Respiration Rate algorithm
    K253186 HemoSphere Nano Monitor (HSNANO1)
    K251982 Edwards MC3 Tricuspid annuloplasty ring (4900)
    K251688 Carpentier-Edwards Physio Annuloplasty Ring (4450)
    K242518 Hypertension Prediction Index (HePI) Algorithm
    K242909 FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
    K240078 Fogarty Thru-Lumen Embolectomy Catheter
    K233984 Acumen Assisted Fluid Management (AFM) Software Feature
    K233824 Swan-Ganz catheter
    K233819 Fogarty Venous Thrombectomy Catheters
    Search all 136 clearances from Edwards Lifesciences, LLC →