510(k) · Cleared
ClearedBlueStar CGM insulin dose calculator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welldoc, Inc. · QRX Continuous Glucose Monitor Informed Insulin Dose Calculator
Cleared on Aug 11, 2023 as substantially equivalent to K203772 (Insulet Corporation, 2022) after a 322-day review. Its family tree reaches back 4 generations to 2018. 2 later devices descend from it.
- Decided
- Aug 11, 2023
- Review
- 322 days
- Class
- Class II
- Product code
- QRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN170043 (2018). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backDEN170043 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2018
- 3 generations backK191370 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2019
- 2 generations backK201476 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2020
- 1 generation backK203772 Omnipod 5 SmartBolus CalculatorInsulet Corporation · 2022
- This deviceK222888 BlueStar CGM insulin dose calculatorWelldoc, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK252818 Dexcom Smart BasalDexcom, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK260062 MODI SystemDreaMed Diabetes, Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN170043 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2018 | — |
| −3 | K191370 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2019 | — |
| −2 | K201476 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2020 | — |
| −1 | K203772 | Omnipod 5 SmartBolus Calculator | Insulet Corporation | 2022 | — |
| 0 (this device) | K222888 | BlueStar CGM insulin dose calculator | Welldoc, Inc. | 2023 | — |
| +1 | K252818 | Dexcom Smart Basal | Dexcom, Inc. | 2025 | — |
| +2 | K260062 | MODI System | DreaMed Diabetes, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QRX device
- #1 K252818 Dexcom Smart Basalscore 14.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203772 | Omnipod 5 SmartBolus CalculatorSummary page 4…21 CFR 862.1358 Regulatory Class: II Classification Panel: Clinical Chemistry Predicate Device: Omnipod 5 SmartBolus Calculator (K203772) 510k Number: K222888… | 2022 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252818 | Dexcom Smart Basal | 2025 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K252818 (Dexcom, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K203772.
How does its category compare?
All QRX devicesQRX Continuous Glucose Monitor Informed Insulin Dose Calculator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QRX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QRX
Too few QRX 510(k)s in any year since 2007 to give a median.
Recalls per year · QRX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QRX
1in 2022
MAUDE reports naming product code QRX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 1 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222888: BlueStar CGM insulin dose calculator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222888
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026