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510(k) Data Aggregation

    K Number
    K253358

    Validate with FDA (Live)

    Device Name
    Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
    Manufacturer
    Diazyme Laboratories, Inc.
    Date Cleared
    2025-12-19

    (80 days)

    Product Code
    DFH
    Regulation Number
    866.5550
    Type
    Traditional
    Panel
    Immunology
    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
    K251152

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    Device Name
    DBLG2
    Manufacturer
    Diabeloop
    Date Cleared
    2025-12-19

    (249 days)

    Product Code
    QJI
    Regulation Number
    862.1356
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K253710

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    Device Name
    Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
    Manufacturer
    Dexcom, Inc.
    Date Cleared
    2025-12-17

    (23 days)

    Product Code
    QBJ
    Regulation Number
    862.1355
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252518

    Validate with FDA (Live)

    Device Name
    DuoprossTM Smart Cap (Type I)
    Manufacturer
    Duopross Meditech Corporate
    Date Cleared
    2025-12-17

    (128 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252273

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    Device Name
    Therapy US
    Manufacturer
    Dmc Importação E Exportação DE Equipamentos Ltda
    Date Cleared
    2025-12-12

    (143 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252343

    Validate with FDA (Live)

    Device Name
    Atlantis® Abutments in Titanium
    Manufacturer
    Dentsply Sirona
    Date Cleared
    2025-12-09

    (134 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    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
    K250805

    Validate with FDA (Live)

    Device Name
    DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
    Manufacturer
    Devilbiss Healthcare, LLC
    Date Cleared
    2025-12-09

    (267 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251829

    Validate with FDA (Live)

    Device Name
    DeGen Medical Patient Specific Implant (PSI) System
    Manufacturer
    Degen Medical
    Date Cleared
    2025-12-08

    (178 days)

    Product Code
    OVD,MAX,PHM
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K251403

    Validate with FDA (Live)

    Device Name
    Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )
    Manufacturer
    Dornier Medtech America Inc (Dmta)
    Date Cleared
    2025-12-05

    (213 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    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
    K252827

    Validate with FDA (Live)

    Device Name
    IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)
    Manufacturer
    Drägerwerk AG & Co, Kgaa
    Date Cleared
    2025-12-01

    (87 days)

    Product Code
    DSA
    Regulation Number
    870.2900
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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