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510(k) Data Aggregation

    K Number
    K251273

    Validate with FDA (Live)

    Device Name
    Asurys Fluid Management System
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2026-03-27

    (337 days)

    Product Code
    HIG
    Regulation Number
    884.1700
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    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
    K252148

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    Device Name
    Butterfly Gestational Age Tool
    Manufacturer
    Butterfly Network, Inc.
    Date Cleared
    2026-03-27

    (261 days)

    Product Code
    IYN,ITX,IYO,QIH
    Regulation Number
    892.1550
    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
    K260601

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    Device Name
    REAL INTELLIGENCE™ CORI™
    Manufacturer
    Blue Belt Technologies, Inc.
    Date Cleared
    2026-03-26

    (30 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    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
    K260281

    Validate with FDA (Live)

    Device Name
    VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
    Manufacturer
    BIOMERIEUX
    Date Cleared
    2026-03-26

    (56 days)

    Product Code
    LON,LTT,LTW
    Regulation Number
    866.1645
    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
    K252052

    Validate with FDA (Live)

    Device Name
    Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
    Manufacturer
    Bausch and Lomb, Incorporated
    Date Cleared
    2026-03-25

    (267 days)

    Product Code
    HQC,HQE,HQF
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic
    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
    K252169

    Validate with FDA (Live)

    Device Name
    Access BNP II
    Manufacturer
    Beckman Coulter, Inc.
    Date Cleared
    2026-03-24

    (257 days)

    Product Code
    NBC
    Regulation Number
    862.1117
    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
    K253750

    Validate with FDA (Live)

    Device Name
    BTL-785NEH
    Manufacturer
    BTL Industries, Inc.
    Date Cleared
    2026-03-17

    (112 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    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
    K254176

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    Device Name
    SINEFIX
    Manufacturer
    BAAT Medical Products B.V.
    Date Cleared
    2026-03-16

    (83 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    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
    K252261

    Validate with FDA (Live)

    Device Name
    InferCare RECIST
    Manufacturer
    Beijing Infervision Healthcare Medical Technology Co., Ltd.
    Date Cleared
    2026-03-13

    (235 days)

    Product Code
    QIH
    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
    K254059

    Validate with FDA (Live)

    Device Name
    Access anti-HBc IgM
    Manufacturer
    Beckman Coulter, Inc.
    Date Cleared
    2026-03-13

    (86 days)

    Product Code
    SEI
    Regulation Number
    866.3173
    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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