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510(k) Data Aggregation

    K Number
    K211507
    Device Name
    Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
    Manufacturer
    Beiang Air Tech LTD.
    Date Cleared
    2022-11-22

    (557 days)

    Product Code
    FRF
    Regulation Number
    880.5045
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K200321
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beiang Air Tech LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Airdog is a mobile air cleaner intended to be used to remove particles from the air for medical purposes. The device is intended for indoor use only. The Airdog has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L4 speed.

    Device Description

    The Airdog X5 Recirculating Air Cleaner is a floor-standing air cleaner with an air quality sensor. The air from the room enters the X5 and passes a pre-filter, ionization frame, ionization field, collecting plates and carbon layer that captures particular matter and virus from the air. The X5 contains multiple PCB modules, air quality sensor, device status indicators, power switch and a display panel it allows user to select between different operation parameter, including auto-mode, sleep mode and wind speed. The Ionization Wireframe and the Collecting Plate can be cleaned routinely and are reusable. X5 is powered from an AC wall outlet. It is intended to be used indoors only.

    AI/ML Overview

    This document is a 510(k) Pre-market Notification from the FDA regarding the Airdog X5 Recirculating Air Cleaner (model KJ300F-X5). It's a regulatory approval document and thus primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed scientific study report with all the requested specifics.

    Based on the provided text, here's the information regarding acceptance criteria and the study that proves the device meets them:

    1. A table of acceptance criteria and the reported device performance

    Performance MetricAcceptance Criteria / Predicate Performance (K200321 Novaerus NV1050)Reported Device Performance (Airdog X5)
    Reduction of Biological AgentsBacillus Globigii endospores and MS2 phage reduced by 3 log in 10 minutes and 4 log in 15 minutes.H3N2 Influenza virus inactivating by 99.99% (4 log) with L4 speed. Staphylococcus albus reduced by 99.99% (4 log) in 1 hour.
    Filtration of Particles4 log reduction in 0.5 to 2.0 μm sized particles in 10 minutes in a 580ft³ (16.4m³) sealed room.Produces a 4 log reduction in PM2.5 particles in 120 minutes in a 30 m³ chamber.
    Ozone EmittedBelow 10 ppb (Implies meeting regulatory requirements, which are typically
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