510(k) · Cleared
ClearedSmartBolus Calculator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insulet Corporation · QRX Continuous Glucose Monitor Informed Insulin Dose Calculator
Cleared on Oct 18, 2023 as substantially equivalent to K222239 (Insulet Corporation, 2022) after a 119-day review. Its family tree reaches back 5 generations to 2018.
- Decided
- Oct 18, 2023
- Review
- 119 days
- Class
- Class II
- Product code
- QRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN170043 (2018). No later device cites it as a predicate yet.
- Root · 5 generations backDEN170043 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2018
- 4 generations backK191370 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2019
- 3 generations backK201476 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2020
- 2 generations backK203772 Omnipod 5 SmartBolus CalculatorInsulet Corporation · 2022
- 1 generation backK222239 SmartBolus CalculatorInsulet Corporation · 2022
- This deviceK231824 SmartBolus CalculatorInsulet Corporation · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN170043 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2018 | — |
| −4 | K191370 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2019 | — |
| −3 | K201476 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2020 | — |
| −2 | K203772 | Omnipod 5 SmartBolus Calculator | Insulet Corporation | 2022 | — |
| −1 | K222239 | SmartBolus Calculator | Insulet Corporation | 2022 | — |
| 0 (this device) | K231824 | SmartBolus Calculator | Insulet Corporation | 2023 | — |
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 |
|---|---|---|---|
| * | K222239 | SmartBolus CalculatorSummary page 4…21 CFR 862.1358 Submission Type: Traditional 510(k) Device Class: Class II Device Predicate: K222239 (SmartBolus Calculator) 5.1 Purpose of Submission The SmartBolus Calculator is being modified to be compatible… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 5 ancestors has a recall.
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 SmartBolus Calculator is software intended for the management of diabetes in persons aged 2 and older requiring rapid-acting U-100 insulin. The SmartBolus Calculator calculates a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose value (or blood glucose reading if using fingerstick), rate of change of the sensor glucose (if applicable), insulin on board (JOB), and programmable correction factor, insulin to carbohydrate ratio, and target glucose value. The SmartBolus Calculator is intended for single patient, home use and requires a prescription.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231824: SmartBolus Calculator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231824
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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