BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PENLON CIRCLE SYSTEM

    K Number: K864588 · Decision Feb 3, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    199
    Registration Numbers
    199
    Same Product Code
    183
    Applicant Total
    28
    Review Days
    74

    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
    PENLON CIRCLE SYSTEM
    K Number
    K864588
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5240
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bear Medical Systems, Inc.
    Date Received
    November 21, 1986
    Decision Date
    February 3, 1987
    Product Code
    CAI
    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
    CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

    Similar 510(k) Clearances

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

    CONDENSATE COLLECTION KIT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    UNICOR, INC. GAS SAMPLING LINES & CONNECTORS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA COAXIAL CIRCUITS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA ADULT GAS SAMPLING CIRCUITS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PRIMA PEDIATRIC ANESTHESIA CIRCUITS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all

    Other Clearances by Bear Medical Systems, Inc.

    K Number Device Name
    K992788 BEAR CUB 750 PSV
    K983981 BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE
    K912619 BEAR 7 VENTILATOR
    K900637 BEAR CEM CONTROLLER
    K896315 BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY
    K893034 VHS 820 HUMIDIFIER, MODIFICATION
    K890724 MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
    K882764 BEAR EVC-100 CONTROLLER
    K881335 BEAR 3 VENTILATOR
    K872660 BEAR NVM-1
    Search all 28 clearances from Bear Medical Systems, Inc. →