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510(k) Data Aggregation

    K Number
    K253847

    Validate with FDA (Live)

    Device Name
    Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
    Manufacturer
    Merit Medical Ireland, Ltd.
    Date Cleared
    2026-01-31

    (60 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Special
    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
    K251769

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    Device Name
    RevealAI-Lung
    Manufacturer
    Precision Medical Ventures, Inc. Dba Revealdx
    Date Cleared
    2026-01-30

    (234 days)

    Product Code
    POK
    Regulation Number
    892.2060
    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
    K254283

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    Device Name
    BruxZir® Shaded 16 PLUS
    Manufacturer
    Prismatik Dentalcraft, Inc.
    Date Cleared
    2026-01-30

    (30 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Special
    Panel
    Dental
    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
    K253318

    Validate with FDA (Live)

    Device Name
    Clungene RSV Antigen Rapid Test
    Manufacturer
    Hangzhou Clongene Biotech Co., Ltd.
    Date Cleared
    2026-01-30

    (122 days)

    Product Code
    GQG
    Regulation Number
    866.3480
    Type
    Traditional
    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
    K253833

    Validate with FDA (Live)

    Device Name
    Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
    Manufacturer
    Shenzhen Jianchao Intelligent Technology Co., Ltd.
    Date Cleared
    2026-01-30

    (60 days)

    Product Code
    OHS,NFO,OLP
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    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
    K250983

    Validate with FDA (Live)

    Device Name
    Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
    Manufacturer
    Asistan Medikal
    Date Cleared
    2026-01-30

    (305 days)

    Product Code
    SCL
    Regulation Number
    880.5570
    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
    K251981

    Validate with FDA (Live)

    Device Name
    Boston PICO (Boston PICO)
    Manufacturer
    Boston Aesthetics, Inc.
    Date Cleared
    2026-01-30

    (217 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    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
    K253671

    Validate with FDA (Live)

    Device Name
    Dual Stage Venous Cannulae
    Manufacturer
    Sorin Group Italia S.R.L.
    Date Cleared
    2026-01-30

    (70 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    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
    K252684

    Validate with FDA (Live)

    Device Name
    Labcorp Fentanyl Urine Visual Test
    Manufacturer
    Medtox Diagnostics, Inc.
    Date Cleared
    2026-01-29

    (157 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Type
    Traditional
    Panel
    Toxicology
    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
    K252603

    Validate with FDA (Live)

    Device Name
    HIGHERDOSE Body Sculptor (Model: GS-03)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd.
    Date Cleared
    2026-01-28

    (163 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    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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