# K162532: WellDoc BlueStar, WellDoc BlueStar Rx

- Pathway: 510(k) (Traditional)
- Applicant: Welldoc, Inc.
- Decided: Jan 12, 2017 after 125 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.
5 later devices descend from it; 1 cites it directly.
0 of 11 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 7.

## Most influential descendants
- K190013: WellDoc BlueStar (2019), 4 descendants of its own
- K193654: BlueStar Rx (2020), 3 descendants of its own
- K203434: BlueStar Rx (2021), 1 descendant of its own
- K230813: BlueStar and BlueStar Rx (2023), 0 descendants of its own
- K221924: Digital Routines (2023), 0 descendants of its own

## Indications for use
The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their adult patients – aged 21 years and older - who have type 2 diabetes. The BlueStar 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 BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar 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 BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment. The WellDoc BlueStar® 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 BlueStar 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 BlueStar® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar 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. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. The BlueStar® 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/K162532
Methodology: https://510kreport.com/methodology