LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253281

    Validate with FDA (Live)

    Device Name
    UpDoc
    Manufacturer
    Updoc, Inc.
    Date Cleared
    2025-12-23

    (85 days)

    Product Code
    NDC
    Regulation Number
    868.1890
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    18 - 120
    Reference & Predicate Devices
    K181916
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    UpDoc is a software as a medical device (SaMD) intended to provide medication management for patients aged 18 years and older who have been diagnosed with type 2 diabetes.

    UpDoc provides patients with insulin treatment plan instructions based on a healthcare provider (HCP)-specified treatment plan.

    UpDoc contains two user-interactive software components:

    • Patient User Interface (UpDoc mobile application): Intended for use by patients with type 2 diabetes as an aid in optimizing insulin management. Patients use the mobile application to log blood glucose, meal, symptom, and medication adherence data, and receive treatment plan instructions. Data may be entered manually or reported via voice or text-based interactions. The application may also receive blood glucose data via a Bluetooth-enabled glucometer or continuous glucose monitor.

    • HCP User Interface (UpDoc web portal): Intended for use by trained healthcare providers to configure and manage the patient-specific insulin treatment plan. This includes insulin dosing instructions (type, starting and maximum doses, adjustment algorithm, and blood glucose targets) and safety protocols to address non-emergency hypoglycemia, hyperglycemia, and related symptoms.

    Insulin instructions are computed in UpDoc's cloud-based application based on the HCP-defined treatment parameters.

    Device Description

    UpDoc is a software as a medical device (SaMD) designed to assist patients aged 18 years and older with insulin management for type 2 diabetes. Healthcare providers (HCPs) set an individualized treatment plan for their patients that includes monitoring and insulin titration instructions. UpDoc engages with patients to help them follow their designated treatment plan and supports HCPs in monitoring reported health data, medication adherence, and treatment progress.

    UpDoc is composed of three modular software components: a provider-facing web portal (UpDoc Provider Portal), a patient mobile application (UpDoc Patient App), and a cloud-based application consisting of a Conversation Service (UpDoc Agent) and a Clinical Service. These components work together to support safe and effective provider-directed insulin therapy.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1