BEUDAMED
    Product Code: ONW FDA class 2 21 CFR 876.5860

    Hemodialysis System For Home Use

    Gastroenterology, Urology

    The Hemodialysis System For Home Use (product code ONW) is a Class 2 device regulated under 21 CFR 876.5860 in the Gastroenterology, Urology specialty (GU), cleared via 510(k). It is designed to provide hemodialysis therapy at home for patients with chronic renal failure, allowing treatment outside of a clinical facility setting. The device is not an implant and is not classified as life-sustaining in the FDA record, despite its critical therapeutic role.

    View on FDA
    510(k)s
    4
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    3
    Years Active
    14

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    Basic Information

    Product Code
    ONW
    Device Class
    FDA class 2
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    To treat and provide hemodialysis therapy at home for chronic renal failure patients.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K242269 SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
    K124035 2008K@HOME HEMODIALYSIS MACHINE
    K121421 FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
    K070049 FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.