BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App

    K Number: K220935 · Decision Dec 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    82
    Applicant Total
    1
    Review Days
    273

    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
    Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
    K Number
    K220935
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Iren-Medical, Ltd.
    Date Received
    March 31, 2022
    Decision Date
    December 29, 2022
    Product Code
    FKX
    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
    FKX System, Peritoneal, Automatic Delivery

    Similar 510(k) Clearances

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

    Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)

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

    Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1

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

    Fresenius Liberty Select Cycler

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

    Lilliput APD System

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

    CloudCath Peritoneal Dialysis Drain Set Monitoring System

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

    Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System

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