BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    F&P Optiflow Air/Oxygen Flow Source

    K Number: K243917 · Decision Jul 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    54
    Applicant Total
    70
    Review Days
    206

    Basic Information

    Device Name
    F&P Optiflow Air/Oxygen Flow Source
    K Number
    K243917
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5330
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fisher & Paykel Healthcare, Ltd.
    Date Received
    December 20, 2024
    Decision Date
    July 14, 2025
    Product Code
    BZR
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BZR Mixer, Breathing Gases, Anesthesia Inhalation

    Similar 510(k) Clearances

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

    Midas Flowmeter; eAVS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Maxtec MaxBlend2+p

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FlowStar Analog Mixer Flowmeter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FlowStar Touch Digital Mixer Flowmeter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Quality Mix Blender, Oxymixer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50

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

    Other Clearances by Fisher & Paykel Healthcare, Ltd.

    K Number Device Name
    K253479 Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
    K250651 OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun
    K252173 F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full
    K251611 Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)
    K234053 F&P Optiflow Flow Diverter
    K233643 F&P Airvo 3 NIV (PT311US)
    K234058 F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)
    K233821 F&P Optiflow Oxygen Kit (AA451J)
    K231956 F&P Optiflow+ Duet Nasal Cannula
    K223684 F&P 820 Humidification System
    Search all 70 clearances from Fisher & Paykel Healthcare, Ltd. →