BEUDAMED
    Product Code: FKY FDA class 2 21 CFR 876.5820

    Connector, Tubing, Dialysate

    Gastroenterology, Urology

    The Dialysate Tubing Connector is a fitting used to join sections of tubing within the dialysate circuit of a hemodialysis delivery system. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKY, regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty. This device is designated as life sustaining or life supporting.

    View on FDA
    510(k)s
    4
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    4
    Years Active
    22

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    Basic Information

    Product Code
    FKY
    Device Class
    FDA class 2
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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

    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
    K991003 PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI
    K862722 TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE
    K830002 CAPD COLOR-GUARD SYSTEM PREPKIT
    K771428 TENCKHOFF PERITONEAL TUBING ADAPT.