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510(k) Data Aggregation

    K Number
    K251742

    Validate with FDA (Live)

    Device Name
    VELO Respiratory Test
    Manufacturer
    Lex Diagnostics Limited
    Date Cleared
    2026-02-13

    (252 days)

    Product Code
    QOF
    Regulation Number
    866.3981
    Type
    Dual Track
    Panel
    Microbiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252565

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    Device Name
    PreOp v3
    Manufacturer
    Clouds of Care
    Date Cleared
    2026-02-13

    (183 days)

    Product Code
    OLX
    Regulation Number
    882.1400
    Type
    Special
    Panel
    Neurology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251852

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    Device Name
    cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
    Manufacturer
    VPIX Medical, Inc.
    Date Cleared
    2026-02-13

    (241 days)

    Product Code
    OWN,GCJ,GWG
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K253133

    Validate with FDA (Live)

    Device Name
    Wrist Blood Pressure Monitor (BPM-W1VL)
    Manufacturer
    Shenzhen Imdk Medical Technology Co., Ltd.
    Date Cleared
    2026-02-13

    (141 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253096

    Validate with FDA (Live)

    Device Name
    Chartis Precision Catheter
    Manufacturer
    Pulmonx Corporation
    Date Cleared
    2026-02-13

    (143 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253089

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    Device Name
    NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
    Manufacturer
    Shenzhen Best Electronics Co., Ltd.
    Date Cleared
    2026-02-13

    (143 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252891

    Validate with FDA (Live)

    Device Name
    MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
    Manufacturer
    Bayer Medical Care, Inc.
    Date Cleared
    2026-02-13

    (155 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253564

    Validate with FDA (Live)

    Device Name
    uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
    Manufacturer
    Shanghai United Imaging Healthcare Co., Ltd.
    Date Cleared
    2026-02-13

    (88 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252685

    Validate with FDA (Live)

    Device Name
    Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)
    Manufacturer
    Joytech Healthcare Co. , Ltd.
    Date Cleared
    2026-02-13

    (171 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K251619

    Validate with FDA (Live)

    Device Name
    Babyleo TN500
    Manufacturer
    Drägerwerk AG & Co KGaA
    Date Cleared
    2026-02-13

    (262 days)

    Product Code
    FMZ
    Regulation Number
    880.5400
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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