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

    ADR-22 AUTOMATIC DIALYZER REPROCESSOR

    K Number: K874034 · Decision Oct 23, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    56
    Applicant Total
    21
    Review Days
    18

    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
    ADR-22 AUTOMATIC DIALYZER REPROCESSOR
    K Number
    K874034
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Biodynamics Corp.
    Date Received
    October 5, 1987
    Decision Date
    October 23, 1987
    Product Code
    LIF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LIF Dialyzer Reprocessing System

    Similar 510(k) Clearances

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

    CLEARFLUX DIALYZER REPROCESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ASSIST HEADER CLEANER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STERICHEK GLUTARALDEHYDE REAGENT STRIPS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RENACLEAN SH DIALYZER CLEANING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MAKY 21.1 DIALYZER REPROCESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ARM AUTOMATIC REPROCESSING MACHINE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Biodynamics Corp.

    K Number Device Name
    K051675 BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER
    K884033 BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER
    K881631 BIODYNAMICS AUTOTRANSFUSION RESERVOIR
    K881968 BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER
    K874361 BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER
    K873807 AUTOTRANSFUSION APPARATUS
    K870052 INFUMIX MIXING CONTAINER
    K822716 UNIVERSAL CENTRIFUGE
    K822715 PLATELET CENTRIFUGE
    K822422 BASIC CENTRIFUGE
    Search all 21 clearances from Biodynamics Corp. →