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

    T-PIECE RESUSCITATOR

    K Number: K142096 · Decision Oct 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    99
    Applicant Total
    15
    Review Days
    77

    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
    T-PIECE RESUSCITATOR
    K Number
    K142096
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5925
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mercury Medical
    Date Received
    August 1, 2014
    Decision Date
    October 17, 2014
    Product Code
    BTL
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BTL Ventilator, Emergency, Powered (Resuscitator)

    Similar 510(k) Clearances

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

    VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Oxymag - Transport and Emergency Ventilator

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VORTRAN GO2VENT with PEEP Valve

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Puffin Lite Infant Resuscitation System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SafeT T-Piece Resuscitator

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

    Other Clearances by Mercury Medical

    K Number Device Name
    K090710 MERCURY CPAP
    K083056 NEO-STAT CO2 <KG
    K032593 MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER
    K031814 STATCO2METER, MODEL 10-55372
    K031411 MINI STATCO2 CO2 DETECTOR, MODEL 10-55371
    K021576 MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370
    K001714 MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149
    K000073 MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA
    K970756 MERCURY MEDICAL REUSABLE CPR BAG
    K954492 MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX
    Search all 15 clearances from Mercury Medical →