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510(k) Data Aggregation

    K Number
    K120566
    Device Name
    O2PAK OXYGEN GENERATOR
    Manufacturer
    PACIFIC PRECISION PRODUCTS
    Date Cleared
    2012-07-24

    (148 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K052396
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The O2PAK™ Portable Oxygen Generator, Model P26029 is intended to provide oxygen for emergency use; the O2PAK™ is currently offered to be used under the Direction of trained medical military personnel in support for disaster relief, crisis response, wartime operations, deterrence and contingency operations, humanitarian relief situations or peacetime engagements.

    Device Description

    The O2PAK™ is designed to be compact, lightweight, portable, durable and easy to carry for emergency use. O2PAK™ Model P26029 is the only O2PAK™ model currently available. Its principle of operation is the same as standard chemical oxygen generators. Oxygen is administered to the patient through a nasal cannula or an equivalent device.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the O2PAK™ Portable Oxygen Generator, Model P26029, based on the provided document.

    Acceptance Criteria and Device Performance

    FeatureAcceptance Criteria (Predicate Device K052396)Reported Device Performance (O2PAK™ Model P26029)
    Intended usesEmergency oxygenEmergency oxygen under supervision of trained personnel. Fits in C-Toms Medical Ruck Sack, or equivalent
    Environments of useNot specifiedLocations where emergency oxygen may be needed.
    Patient populationsNot specifiedAdult individuals requiring oxygen in an emergency setting.
    Solid state chemical oxygen generationYesYes
    PortableYesYes
    Flow rateApproximately 6.5 liters per minute4 to 8 liters per minute
    Flow Delivery Accuracy6 liters per minute for 15 minutesMinimum 4 liters per minute for minimum of 22 minutes
    Total Oxygen CapacityApproximately 90 litersMinimum of 90 liters
    Medically pure [USP] oxygenUSP 99%USP 99% Oxygen
    Oxygen Outlet TemperatureUnknownMaximum 6°C above ambient (at patient)
    Oxygen Outlet PressureUnknown30 psig maximum during initial surge, 3 psig maximum during operation
    Single use, disposableNot specifiedYes
    Self-containedNot specifiedYes (Cannula NOT included)
    Generator storage lifeNot specified48 months
    WeightNot specified
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