# K193654: BlueStar Rx

- Pathway: 510(k) (Traditional)
- Applicant: Welldoc, Inc.
- Decided: Apr 7, 2020 after 99 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: 9 generations back to K010362 (2001). 23 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190013: WellDoc BlueStar, Welldoc, Inc. (2019) Summary page 5.
- K171450: Glooko Mobile Insulin Dosing System, Glooko, Inc. (2018) Summary page 5.

## Most influential descendants
- 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
BlueStar® Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. The BlueStar® Rx 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 analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar® Rx 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. • For bolus insulin users with type 1 and type 2 diabetes, BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value. • For basal insulin users with type 2 diabetes, BlueStar® Rx includes an Insulin Adjustment Program (IAP) which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider knowledgeable in the care and management of diabetes. The healthcare provider must activate the Insulin Adjustment Program and configure it for patient-specific parameters. The BlueStar® Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Source page: https://510kreport.com/device/K193654
Methodology: https://510kreport.com/methodology