# K203434: BlueStar Rx

- Pathway: 510(k) (Traditional)
- Applicant: Welldoc, Inc.
- Decided: Sep 8, 2021 after 289 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
Longest line of descent: 10 generations back to K010362 (2001). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193654: BlueStar Rx, Welldoc, Inc. (2020) Summary page 4.

## Most influential descendants
- 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. BlueStar® Rx analyzes, and reports blood glucose test results and supports medication adherence. In addition, 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 to aid in diabetes self-management. • For bolus insulin users with type 1 or 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. • For bolus insulin users with type 2 diabetes, BlueStar® Rx’s IAP calculates appropriate dose adjustments of bolus insulin based on configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets despite optimization of their basal insulin dose or their current bolus insulin regimen. • For premixed insulin users with type 2 diabetes, BlueStar® Rx’s IAP calculates appropriate dose adjustments of premixed insulin based on the configuration of a healthcare provider. Qualified type 2 diabetes patients are those who are not achieving glycemic targets and who do not take other types of insulin. The algorithms for the IAP are not designed for the titration of NPH, regular human insulin, or human premixed insulins. The healthcare provider must activate the IAP and configure it with patient-specific parameters. 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/K203434
Methodology: https://510kreport.com/methodology