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510(k) Data Aggregation

    K Number
    K251970

    Validate with FDA (Live)

    Device Name
    Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
    Manufacturer
    Medtronic, Ireland
    Date Cleared
    2026-01-17

    (205 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    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
    DEN250005

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    Device Name
    Sana Device
    Manufacturer
    Sana Health
    Date Cleared
    2026-01-16

    (319 days)

    Product Code
    QYN
    Regulation Number
    N/A
    Type
    Direct
    Panel
    Neurology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K252960

    Validate with FDA (Live)

    Device Name
    SOLIUS PRO UVB Light Panel
    Manufacturer
    Solius Labs, Inc.
    Date Cleared
    2026-01-16

    (122 days)

    Product Code
    RAB
    Regulation Number
    878.4635
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K251790

    Validate with FDA (Live)

    Device Name
    SeptAlign
    Manufacturer
    Spirair, Inc.
    Date Cleared
    2026-01-16

    (219 days)

    Product Code
    MHB
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K251847

    Validate with FDA (Live)

    Device Name
    Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
    Manufacturer
    Sleepnet Corporation
    Date Cleared
    2026-01-15

    (213 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    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
    K251961

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    Device Name
    SDS Growing Rod
    Manufacturer
    BAAT Medical Products B.V.
    Date Cleared
    2026-01-15

    (203 days)

    Product Code
    PGM
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K251308

    Validate with FDA (Live)

    Device Name
    SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
    Manufacturer
    Thera B Medical Products
    Date Cleared
    2026-01-15

    (262 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    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
    K253585

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    Device Name
    SmartGuard technology; Predictive Low Glucose technology
    Manufacturer
    Medtronic Minimed, Inc.
    Date Cleared
    2026-01-14

    (58 days)

    Product Code
    QJI
    Regulation Number
    862.1356
    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
    K252461

    Validate with FDA (Live)

    Device Name
    Swedge™ Pedicle Screw Fixation System Bezier Rod
    Manufacturer
    Spinal Resources, Inc.
    Date Cleared
    2026-01-13

    (161 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    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
    K251701

    Validate with FDA (Live)

    Device Name
    Star E900 Electric System
    Manufacturer
    Dentalez, Inc., Stardental Division
    Date Cleared
    2026-01-12

    (224 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    Type
    Traditional
    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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