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510(k) Data Aggregation

    K Number
    K252241

    Validate with FDA (Live)

    Device Name
    Pressio 3 Multi-parameter Neuromonitoring System
    Manufacturer
    Sophysa
    Date Cleared
    2026-04-10

    (267 days)

    Product Code
    GWM
    Regulation Number
    882.1620
    Type
    Traditional
    Panel
    Neurology
    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
    K260430

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    Device Name
    Porcelain Etch Gel
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2026-04-10

    (59 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    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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    K Number
    K260839

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    Device Name
    Protaryx Transseptal Puncture Device (PTX2-001)
    Manufacturer
    Protaryx Medical, Inc.
    Date Cleared
    2026-04-10

    (28 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    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
    K260017

    Validate with FDA (Live)

    Device Name
    Picosecond Nd:YAG Laser Systems (Model: HS-298)
    Manufacturer
    Shanghai Apolo Medical Technology Co., Ltd.
    Date Cleared
    2026-04-09

    (94 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
    K253268

    Validate with FDA (Live)

    Device Name
    Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
    Manufacturer
    CMT Health PTE., Ltd.
    Date Cleared
    2026-04-08

    (191 days)

    Product Code
    PNR
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    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
    K253534

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    Device Name
    Pivot Insulin Delivery System
    Manufacturer
    Modular Medical
    Date Cleared
    2026-04-08

    (146 days)

    Product Code
    LZG
    Regulation Number
    880.5725
    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
    K253952

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    Device Name
    Power Wheelchair (OS-R-M01S)
    Manufacturer
    Beijing OrionStar Technology Co., Ltd.
    Date Cleared
    2026-04-07

    (118 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    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
    K260860

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    Device Name
    Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
    Manufacturer
    Basic Medical Technology, Inc.
    Date Cleared
    2026-04-07

    (22 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    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
    K253905

    Validate with FDA (Live)

    Device Name
    PrimeSight UltraView System
    Manufacturer
    Cogentix Medical, Inc.
    Date Cleared
    2026-04-07

    (123 days)

    Product Code
    FAJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    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
    K252765

    Validate with FDA (Live)

    Device Name
    ProSomnus RPMO2 OSA Device (RPMO2 OSA)
    Manufacturer
    Prosomnus Sleep Technologies
    Date Cleared
    2026-04-06

    (220 days)

    Product Code
    PLC,DQA,LQZ,LRK,OUG
    Regulation Number
    872.5570
    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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