# K162225: WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System

- Pathway: 510(k) (Traditional)
- Applicant: Welldoc, Inc.
- Decided: Nov 22, 2016 after 106 days
- Product code: MRZ (Accessories, Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001907 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100066: Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1, Welldoc, Inc. (2010) Summary page 6.

## Indications for use
DiabetesManager® (OTC Use): The WellDoc DiabetesManager® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older -who have type 2 diabetes. The DiabetesManager® System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The DiabetesManager® System analyzes and reports blood glucose test results and supports medication adherence. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. The DiabetesManager® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. DiabetesManager®-Rx (Prescription Use): The WellDoc DiabetesManager®-Rx System is indicated for use by healthcare providers (HCPs) and their adult patients — aged 21 years and older - who have type 2 diabetes. The DiabetesManager®-Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The DiabetesManager®-Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the DiabetesManager®-Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. The DiabetesManager®-Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Source page: https://510kreport.com/device/K162225
Methodology: https://510kreport.com/methodology