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510(k) Data Aggregation

    K Number
    K251900

    Validate with FDA (Live)

    Device Name
    MY01 Continuous Compartmental Pressure Monitor
    Manufacturer
    MY01, Inc.
    Date Cleared
    2026-01-16

    (210 days)

    Product Code
    LXC
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Orthopedic
    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
    K253470

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    Device Name
    MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)
    Manufacturer
    Medtronic Minimed, Inc.
    Date Cleared
    2026-01-15

    (97 days)

    Product Code
    QFG
    Regulation Number
    880.5730
    Type
    Traditional
    Panel
    Clinical Chemistry
    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
    K252958

    Validate with FDA (Live)

    Device Name
    METICULY Patient-specific titanium mesh implant
    Manufacturer
    Meticuly Co., Ltd.
    Date Cleared
    2026-01-14

    (120 days)

    Product Code
    GXN
    Regulation Number
    882.5330
    Type
    Traditional
    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
    K253075

    Validate with FDA (Live)

    Device Name
    Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)
    Manufacturer
    Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
    Date Cleared
    2026-01-09

    (108 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    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
    K253512

    Validate with FDA (Live)

    Device Name
    MiniMed Go App
    Manufacturer
    Medtronic Minimed
    Date Cleared
    2026-01-08

    (63 days)

    Product Code
    NDC
    Regulation Number
    868.1890
    Type
    Traditional
    Panel
    Clinical Chemistry
    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
    K253308

    Validate with FDA (Live)

    Device Name
    Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
    Manufacturer
    Materialise N.V
    Date Cleared
    2026-01-07

    (100 days)

    Product Code
    PPT
    Regulation Number
    882.4310
    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
    K252749

    Validate with FDA (Live)

    Device Name
    Medconn 8K Glycated Hemoglobin Test System
    Manufacturer
    Shanghai Medconn Medical Technology Co., Ltd.
    Date Cleared
    2026-01-06

    (130 days)

    Product Code
    PDJ
    Regulation Number
    862.1373
    Type
    Traditional
    Panel
    Clinical Chemistry
    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
    K253793

    Validate with FDA (Live)

    Device Name
    Materialise TKA Guide System
    Manufacturer
    Materialise N.V
    Date Cleared
    2026-01-06

    (39 days)

    Product Code
    JWH,MBH,OIY,OOG
    Regulation Number
    888.3560
    Type
    Special
    Panel
    Orthopedic
    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
    K253008

    Validate with FDA (Live)

    Device Name
    maiLink
    Manufacturer
    Maihub Corp.
    Date Cleared
    2026-01-05

    (108 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    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
    K253854

    Validate with FDA (Live)

    Device Name
    MONTAGE XT Cranial Cement
    Manufacturer
    Abyrx, Inc.
    Date Cleared
    2026-01-02

    (30 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    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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