510(k) · Cleared
ClearedOmnipod 5 SmartBolus 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 Jan 27, 2022 as substantially equivalent to K201476 (DreaMed Diabetes, Ltd., 2020) after a 400-day review. Its family tree reaches back 3 generations to 2018. 5 later devices descend from it.
- Decided
- Jan 27, 2022
- Review
- 400 days
- Class
- Class II
- Product code
- QRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170043 (2018). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN170043 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2018
- 2 generations backK191370 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2019
- 1 generation backK201476 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2020
- This deviceK203772 Omnipod 5 SmartBolus CalculatorInsulet Corporation · 2022
- Descendant · cites it directly · 2 of its ownK222888 BlueStar CGM insulin dose calculatorWelldoc, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK252818 Dexcom Smart BasalDexcom, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK222239 SmartBolus CalculatorInsulet Corporation · 2022
- Descendant · 3 generations on · 0 of its ownK260062 MODI SystemDreaMed Diabetes, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK231824 SmartBolus CalculatorInsulet Corporation · 2023
Most influential descendants
Showing 5 of 5 · See all- K222888BlueStar CGM insulin dose calculatorWelldoc, Inc. · 2023 · cites it directly2descendants
- K252818Dexcom Smart BasalDexcom, Inc. · 2025 · 2 generations on1descendant
- K222239SmartBolus CalculatorInsulet Corporation · 2022 · cites it directly1descendant
- K260062MODI SystemDreaMed Diabetes, Ltd. · 2026 · 3 generations on0descendants
- K231824SmartBolus CalculatorInsulet Corporation · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN170043 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2018 | — |
| −2 | K191370 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2019 | — |
| −1 | K201476 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2020 | — |
| 0 (this device) | K203772 | Omnipod 5 SmartBolus Calculator | Insulet Corporation | 2022 | — |
| +1 | K222888 | BlueStar CGM insulin dose calculator | Welldoc, Inc. | 2023 | — |
| +2 | K252818 | Dexcom Smart Basal | Dexcom, Inc. | 2025 | — |
| +1 | K222239 | SmartBolus Calculator | Insulet Corporation | 2022 | — |
| +3 | K260062 | MODI System | DreaMed Diabetes, Ltd. | 2026 | — |
| +2 | K231824 | SmartBolus Calculator | Insulet Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K201476 | DreaMed Advisor ProSummary page 4…21 CFR 868.1890 Submission Type: Traditional 510(k) Device Class: Class II Device Predicate: K201476, DreaMed Advisor Pro Insulet Corporation Traditional 510(k) Omnipod 5 SmartBolus Calculator Device Desc… | 2020 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K222888 (Welldoc, Inc., 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K201476.
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. 2022, 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 Omnipod 5 SmartBolus Calculator is software intended for the management of diabetes in persons aged 6 and older requiring rapid-acting U-100 insulin. The Omnipod 5 SmartBolus Calculator calculates a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose reading (or blood glucose reading if using fingerstick), rate of change of the sensor glucose (if applicable), insulin on board (IOB), and programmable correction factor, insulin to carbohydrate ratio, and target glucose value. The Omnipod 5 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/K203772 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203772: Omnipod 5 SmartBolus Calculator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203772
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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