# K163099: My Dose Coach

- Pathway: 510(k) (Traditional)
- Applicant: Sanofi, Inc.
- Decided: Mar 22, 2017 after 135 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
My Dose Coach is indicated for single patient use outside the clinic setting by a previously diagnosed Type 2 Diabetic who has been prescribed a once-daily long-acting basal insulin. My Dose Coach is intended as an aid to the patient to provide dose suggestions based upon the HCP’s independent professional judgment. Before My Dose Coach can be used, the HCP configures the dose instructions for the specific patient and activates the application using the specific patient instructions. The application uses the dose plan instructions provided by the patient’s HCP to provide dose suggestions of once-daily long-acting basal insulin (i.e. basal insulin titration) that are based on the patient’s Fasting Blood Glucose (FBG) as well as hypoglycemia occurrence. My Dose Coach is not intended to replace the care or advice of a physician or HCP.

Source page: https://510kreport.com/device/K163099
Methodology: https://510kreport.com/methodology