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510(k) Data Aggregation

    K Number
    K252818

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-11-18

    (75 days)

    Product Code
    Regulation Number
    862.1358
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dexcom Smart Basal insulin dose calculator is software intended for the management of type 2 diabetes in persons aged 18 years and older requiring long-acting insulin. This is not for use for patients on fast-acting insulin. The Dexcom Smart Basal insulin dose calculator calculates a dose of basal (long-acting) insulin using logged doses and glucose measurements from an integrated continuous glucose monitor (iCGM). The Dexcom Smart Basal insulin dose calculator requires a prescription and initial configuration by a healthcare provider.

    Device Description

    The Dexcom Smart Basal system is a basal insulin (long-acting insulin) dose calculator intended for use by individuals with type 2 diabetes. It requires a prescription and initial configuration by a healthcare provider (HCP). The Dexcom Smart Basal system is designed to optimize and recommend basal insulin doses for patients who use compatible Dexcom CGM systems. The Dexcom Smart Basal system produces daily basal dose recommendations using the patients' CGM data, insulin dose logs, and HCP-entered patient-specific treatment parameters. The Dexcom Smart Basal system is comprised of applications that initiate and manage the basal titration process for patients with type 2 diabetes who may benefit from long-term insulin treatment.

    The Dexcom Smart Basal system consists of a cloud-based long-acting insulin dose calculator, a patient facing module within a compatible CGM system mobile application, and a web-based provider-facing user interface.

    AI/ML Overview

    N/A

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