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510(k) Data Aggregation

    K Number
    K251050

    Validate with FDA (Live)

    Device Name
    Pectus Versa System
    Manufacturer
    Gm Dos Reis Industria E Comercio
    Date Cleared
    2025-12-19

    (260 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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    K Number
    K253616

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    Device Name
    ProtekDilate Vascular Access Kit
    Manufacturer
    Sorin Group Italia S.R.L.
    Date Cleared
    2025-12-19

    (31 days)

    Product Code
    DRE
    Regulation Number
    870.1310
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252976

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    Device Name
    Park Dental Nylon MAD
    Manufacturer
    Park Dental Research Corp.
    Date Cleared
    2025-12-18

    (92 days)

    Product Code
    LRK
    Regulation Number
    872.5570
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252235

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    Device Name
    PVAD IQ Software
    Manufacturer
    Ultrasight , Ltd.
    Date Cleared
    2025-12-18

    (154 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252204

    Validate with FDA (Live)

    Device Name
    prolaio eVO2peak Module (Version 1.0)
    Manufacturer
    Prolaio, Inc.
    Date Cleared
    2025-12-16

    (155 days)

    Product Code
    PPW
    Regulation Number
    870.2200
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
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    K Number
    K251256

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    Device Name
    PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
    Manufacturer
    Pentax of America, Inc.
    Date Cleared
    2025-12-16

    (237 days)

    Product Code
    FDS
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252950

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    Device Name
    Paradigm System
    Manufacturer
    Proprio, Inc.
    Date Cleared
    2025-12-15

    (90 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252090

    Validate with FDA (Live)

    Device Name
    Pterygoid Indication for GM Helix Implants
    Manufacturer
    JJGC Indústria e Comércio de Materiais Dentários S.A.
    Date Cleared
    2025-12-12

    (163 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K252154

    Validate with FDA (Live)

    Device Name
    Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)
    Manufacturer
    Guangzhou Longest Medical Technology Co., Ltd.
    Date Cleared
    2025-12-09

    (153 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K250795

    Validate with FDA (Live)

    Device Name
    PUREVUE™ FMS
    Manufacturer
    W.O.M. World OF Medicine GmbH
    Date Cleared
    2025-12-05

    (266 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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