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510(k) Data Aggregation

    K Number
    K211194
    Device Name
    Molekule Air Pro
    Manufacturer
    Molekule, Inc.
    Date Cleared
    2021-08-20

    (121 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Molekule, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Molekule Air Pro air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria, mold, and viruses by exposure to ultraviolet radiation when operated in Auto Mode Standard or manual mode at fan speed 2 or higher. The Molekule Air Pro air purifier has been demonstrated to entrain and destroy the following bioaerosols under the following exposure/working conditions: | Test Item | | Average Net Log Reduction / Time @ Fan Speed 6. Room Temperature Test | |---------------------|----------------------------------|-----------------------------------------------------------------------| | Bacteria | Escherichia Coli | $4.20 \pm 0.11$ / 90 minutes | | Bacteria Endospores | Bacillus Subtilis | $4.02 \pm 0.23$ / 30 minutes | | Mold Spores | Aspergillus Brasiliensis | $4.15 \pm 0.06$ / 60 minutes | | Virus | MS2 bacteriophage | $4.38 \pm 0.15$ / 30 minutes | | Test Item | | Single Pass Mechanical Filtration Efficiency | | Particulate Matter | 0.3 to 1.0 micron size particles | 95% or greater according to ASHRAE 52.2 |
    Device Description
    The Molekule Air Pro air purifier is an ultraviolet air purifier that employs a photo electrochemical oxidation (PECO) ultraviolet air purification technology that destroys bacteria and viruses in air. The Molekule Air Pro may be used in medical facilities and in the home. A fan within the unit draws air up from vents in the bottom of the unit, up through the PECO filter (where it is exposed to low energy UV-A 320 - 400 nm light) and out through the vents on the top of the unit. PECO is an air purification technology that oxidizes microorganisms, including bacteria, molds and viruses. PECO works by shining UV-A light on the surface of the catalytic filter to initiate a chemical reaction that generates hydroxyl radicals. These radicals combine with microbiological contaminants that are captured on the filter. Once combined, a chemical reaction takes place destroying the contaminants. The Molekule Air Pro is a freestanding device. It is a standalone device with an LCD display and a capacitive touchscreen user interface. Integrated WLAN provides a secondary means for controlling the device from the Molekule Android or iOS application. Air Pro also includes a particulate matter sensor, particulate matter indicator, and Auto Protect Mode, which controls fan speed based on particulate levels detected in the use environment.
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    K Number
    K202339
    Device Name
    Molekule Air Mini, Molekule Air Mini +
    Manufacturer
    Molekule, Inc.
    Date Cleared
    2021-02-23

    (190 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Molekule, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Molekule Air Mini air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria and viruses by exposure to ultraviolet radiation. The Molekule Air Mini air purifier has been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure/working conditions: Virus: MS2 bacteriophage - Average maximum log reduction / entrainment time (hours) at Fan Speed 5. Room temperature test. 5.09 ± 0.42 / 120 mins Particulate matter: 0.3 to 1.0 micron size particles - Single Pass Mechanical Filtration Efficiency 95% or greater according to ASHRAE 52.2 The Molekule Air Mini + air purifier is a device intended for medical purposes that is used to capture 95% of particulate matter and destroy bacteria and viruses by exposure to ultraviolet radiation when operated in manual mode at fan speed 3 or higher. The Molekule Air Mini + air purifier has been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure/working conditions: Virus: MS2 bacteriophage - Average maximum log reduction / entrainment time (hours) at Fan Speed 5. Room temperature test. 5.09 ± 0.42 / 120 mins Particulate matter: 0.3 to 1.0 micron size particles - Single Pass Mechanical Filtration Efficiency 95% or greater according to ASHRAE 52.2
    Device Description
    The Molekule Air Mini and Air Mini + air purifiers are ultraviolet air purifiers that employ a photo electrochemical oxidation (PECO) ultraviolet air purification technology that destroys bacteria and viruses in air. The Molekule Air Mini and Air Mini + may be used in medical facilities and in the home. The Molekule Air Mini and Air Mini + air purifiers includes a low energy ultraviolet light (UV-A 320 - 400 nm) and a catalytic filter. They are standalone devices that can be controlled via a button on the device and may also be controlled using the Molekule Android or iOS application. PECO is an air purification technology that oxidizes bacteria and viruses. PECO works by shining UV-A light on the surface of the catalytic filter to initiate a chemical reaction that generates hydroxyl radicals. These radicals combine with microbiological contaminants, such as bacteria and viruses, that are captured on the filter. Once combined, a chemical reaction takes place destroying the contaminants. The Molekule Air Mini and Air Mini + are freestanding devices. A fan within the unit draws air up from vents in the bottom of the unit, up through the PECO filter (where it is exposed to UV-A light), and out through the vents on the top of the unit. The Molekule Air Mini and Air Mini + user interface includes a capacitive touch button and LED indicators on the top of the device. Power (on/off) and fan speed are controlled via the capacitive touch button. Integrated WLAN provides a secondary means for controlling the device from the Molekule Android or iOS application. Air Mini + additionally includes a particulate matter sensor, particulate matter indicator, and Auto Protect Mode, which controls fan speed based on particulate levels detected in the use environment.
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    K Number
    K200500
    Device Name
    Molekule Air Pro RX
    Manufacturer
    Molekule, Inc.
    Date Cleared
    2020-04-15

    (47 days)

    Product Code
    FRA
    Regulation Number
    880.6500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Molekule, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Molekule Air Pro RX air purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation. The core technology components of the Molekule Air Pro RX air purifier have been demonstrated to destroy the following MS2 bacteriophage bioaerosol entrained on the filter of the subject device under the following exposure conditions: | Organism | Name | Average Maximum log reduction<br>/exposure time (hours) | |----------|-------------------|---------------------------------------------------------| | | | Room temperature test | | Virus | MS2 bacteriophage | 5.21 / 24 hours |
    Device Description
    The Molekule Air Pro RX air purifier employs a photo-electrochemical oxidation (PECO) ultraviolet air purification technology that destroys bacteria, viruses and mold in air in medical facilities. The Molekule Air Pro RX air purifier includes a pre-filter and low energy ultraviolet lights (UV-A 320-400 nm), and a catalytic filter.
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