# K222888: BlueStar CGM insulin dose calculator

- Pathway: 510(k) (Traditional)
- Applicant: Welldoc, Inc.
- Decided: Aug 11, 2023 after 322 days
- Product code: QRX (Continuous Glucose Monitor Informed Insulin Dose Calculator)
- Device class: 2
- Regulation: 21 CFR 862.1358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN170043 (2018). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203772: Omnipod 5 SmartBolus Calculator, Insulet Corporation (2022) Summary page 4.

## Most influential descendants
- K252818: Dexcom Smart Basal (2025), 1 descendant of its own
- K260062: MODI System (2026), 0 descendants of its own

## Indications for use
The BlueStar® CGM insulin dose calculator is software intended for the management of type 1 or type 2 diabetes in persons aged 18 years and older requiring fast-acting insulin. The BlueStar CGM insulin dose calculator allows patients to calculate a dose of bolus insulin for a given amount of carbohydrates, the most recent CGM glucose reading and rate of change, activity, and, optionally, insulin on board (IOB). The BlueStar CGM insulin dose calculator requires a prescription.

Source page: https://510kreport.com/device/K222888
Methodology: https://510kreport.com/methodology