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

    REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM

    K Number: K894299 · Decision Sep 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    115
    Applicant Total
    6
    Review Days
    92

    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
    REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM
    K Number
    K894299
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.6810
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Repro-Med Systems, Inc.
    Date Received
    June 22, 1989
    Decision Date
    September 22, 1989
    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 Repro-Med Systems, Inc.

    K Number Device Name
    K102512 RMS SUBCUTANEOUS NEEDLE SET
    K981506 RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)
    K933652 FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING
    K892529 REPRO-MED NEONATE ASPIRATION SYSTEM
    K844401 REPRO-MED SYSTEMS INFUSION DEVICE