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510(k) Data Aggregation

    K Number
    K252006

    Validate with FDA (Live)

    Device Name
    OTTO™ Disinfecting Cap
    Manufacturer
    Icu Medical, Inc.
    Date Cleared
    2026-03-27

    (273 days)

    Product Code
    QBP
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    K130975
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    OTTO is intended for use on swabbable needlefree connectors as a cover to protect the needlefree connectors from potential contamination. OTTO acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access.

    OTTO will disinfect the connector thirty (30) seconds after application and maintains a disinfected connector surface for up to seven (7) days if not removed.

    Device Description

    The OTTO™ Disinfecting Cap is a sterile disposable cap designed to disinfect swabbable needlefree female connectors with 70% isopropyl alcohol (IPA) when attached to an intravenous (IV) catheter. The OTTO™ product line complements the ICU Medical Clave family of needlefree connectors; however, it is designed to work with other on-market swabbable needlefree female connectors used in peripheral intravenous catheters, indwelling central venous or arterial access catheters.

    AI/ML Overview

    N/A

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