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

    PEDIATRIC BUBBLE TRAP CAT. NO. B-100

    K Number: K873610 · Decision Nov 5, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    115
    Applicant Total
    20
    Review Days
    58

    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
    PEDIATRIC BUBBLE TRAP CAT. NO. B-100
    K Number
    K873610
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.6810
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    American Omni Medical, Inc.
    Date Received
    September 8, 1987
    Decision Date
    November 5, 1987
    Product Code
    BSY
    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
    BSY Catheters, Suction, Tracheobronchial

    Similar 510(k) Clearances

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

    MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    AMBU HAND POWER SUCTION PUMP

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    DUAL PURPOSE CLOSED CATHETER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    SUCTION CATHETER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    HI-CARE CLOSED SUCTION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    AMSINO SUCTION CATHETER

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

    Other Clearances by American Omni Medical, Inc.

    K Number Device Name
    K922781 FLOW CONROL VALVE
    K922356 FLOW CONTROL VALVE, CAT. NO. ACV-38
    K900672 PREBYPASS FILTER, CAT. NO. FPB-5
    K884893 CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25
    K884640 CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700
    K873316 BUBBLE TRAP-FILTER CAT. NO B180F37
    K875080 AIR VENT LINE CAT. NO. AVL-36
    K873802 PRESSURE BARRIER KIT CAT. NO. PBK-3
    K873488 SILENT GUARD CAT. NO. SG-10
    K871632 NASOGASTRIC VOICETUBE
    Search all 20 clearances from American Omni Medical, Inc. →