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My Dose Coach

by Sanofi, Inc.

510(k) K163099

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK163099 Date22 Mar 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NDC
Device Class
Class II
Regulation
21 CFR Part 868.1890
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

My Dose Coach is a calculator drug dose device classified under medical specialty Anesthesiology. It is a digital insulin titration tool designed for basal insulin management.

It is supplied as a software application for use by adult patients with type 2 diabetes who are prescribed once-daily long-acting basal insulin or basal insulin plus GLP-1 receptor agonist under healthcare provider supervision. The device requires healthcare provider registration and dose plan transmission for use, and is authorized under FDA 510(k) clearance K163099.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is My Dose Coach used for?

    My Dose Coach is a digital insulin titration tool designed to assist adult patients with type 2 diabetes in managing once-daily long-acting basal insulin or basal insulin plus GLP-1 receptor agonist therapy under healthcare provider supervision. It helps calculate and guide dose adjustments based on patient data transmitted by the provider.

  • How is My Dose Coach supplied to users?

    My Dose Coach is supplied as a software application intended for use by adult patients with type 2 diabetes. It requires healthcare provider registration and transmission of a personalized dose plan before the patient can use the device, ensuring clinical oversight and individualized treatment guidance.

  • Is My Dose Coach a single-use or reusable device?

    My Dose Coach is a reusable software application designed for ongoing use by patients over time. It supports continuous basal insulin management through repeated interactions, with dose plans updated and transmitted by healthcare providers as needed, making it a reusable digital tool rather than a single-use product.