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

    PERCUPUMP (TM)

    K Number: K864227 · Decision Jan 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    56
    Review Days
    80

    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
    PERCUPUMP (TM)
    K Number
    K864227
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    E-Z-Em, Inc.
    Date Received
    October 28, 1986
    Decision Date
    January 16, 1987
    Product Code
    FRN
    Advisory Committee
    General Hospital
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRN Pump, Infusion

    Similar 510(k) Clearances

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

    FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SIGMA Spectrum Infusion Pump with Master Drug Library

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MRidium 3870 MRI Infusion Pump System (3870)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD Alaris Infusion System with Guardrails Suite MX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Plum Solo™ Precision IV Pump

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by E-Z-Em, Inc.

    K Number Device Name
    K071378 MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
    K062449 EMPOWERMR INJECTOR SYSTEM, MODEL 9730
    K063029 EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900
    K053008 E-Z-EM ENDOSCOPIC CO2 REGULATOR
    K041178 EMPOWER TRANSFER SET, (CAT. NO. 7725)
    K031571 EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
    K030854 PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
    K013219 PROTOCO2L INSUFFLATOR MODEL 6400
    K011160 E-Z EM PERCUPUMP 2001 CT INJECTOR
    K974621 PERCUPUMP II WITH EDA
    Search all 56 clearances from E-Z-Em, Inc. →