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510(k) Data Aggregation

    K Number
    K250523

    Validate with FDA (Live)

    Device Name
    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)
    Manufacturer
    Simergent, LLC
    Date Cleared
    2025-10-02

    (223 days)

    Product Code
    FKX
    Regulation Number
    876.5630
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K002892,K822549
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Archimedes APD system is an Automated Peritoneal Dialysis system indicated for acute and chronic peritoneal dialysis for adult patients in clinical and home use. A care partner is not required. The following therapies are supported: Continuous Cyclic Peritoneal Dialysis (CCPD) and Intermittent Peritoneal Dialysis (IPD). Mid-day exchanges are not supported.

    Device Description

    The proposed system is an automated peritoneal dialysis (APD) cycler which consists of a heater unit, control unit, cart, drain containers, and disposable tubing set.

    AI/ML Overview

    N/A

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