BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EXCELERON BACTERIAL FILTERS

    K Number: K131626 · Decision Feb 26, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    2
    Review Days
    267

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EXCELERON BACTERIAL FILTERS
    K Number
    K131626
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exceleron Medical
    Date Received
    June 4, 2013
    Decision Date
    February 26, 2014
    Product Code
    CAH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAH Filter, Bacterial, Breathing-Circuit

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CAH), ordered by most recent decision date.

    Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Ambu® Virobac II® Exhalation Filter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Besmed Bacterial Filter and HMEF

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Breathing circuit bacterial/viral filter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TNI Clear-Guard™ 3 angled breathing filter (1545020)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Exceleron Medical

    K Number Device Name
    K241268 Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)