510(k) · Cleared
ClearedMODI System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DreaMed Diabetes, Ltd. · QRX Continuous Glucose Monitor Informed Insulin Dose Calculator
Cleared on Sep 8, 2026 as substantially equivalent to K252818 (Dexcom, Inc., 2025) after a 243-day review. Its family tree reaches back 6 generations to 2018.
- Decided
- Sep 8, 2026
- Review
- 243 days
- Class
- Class II
- Product code
- QRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN170043 (2018). No later device cites it as a predicate yet.
- Root · 6 generations backDEN170043 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2018
- 5 generations backK191370 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2019
- 4 generations backK201476 DreaMed Advisor ProDreaMed Diabetes, Ltd. · 2020
- 3 generations backK203772 Omnipod 5 SmartBolus CalculatorInsulet Corporation · 2022
- 2 generations backK222888 BlueStar CGM insulin dose calculatorWelldoc, Inc. · 2023
- 1 generation backK252818 Dexcom Smart BasalDexcom, Inc. · 2025
- This deviceK260062 MODI SystemDreaMed Diabetes, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN170043 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2018 | — |
| −5 | K191370 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2019 | — |
| −4 | K201476 | DreaMed Advisor Pro | DreaMed Diabetes, Ltd. | 2020 | — |
| −3 | K203772 | Omnipod 5 SmartBolus Calculator | Insulet Corporation | 2022 | — |
| −2 | K222888 | BlueStar CGM insulin dose calculator | Welldoc, Inc. | 2023 | — |
| −1 | K252818 | Dexcom Smart Basal | Dexcom, Inc. | 2025 | — |
| 0 (this device) | K260062 | MODI System | DreaMed Diabetes, Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K252818 | Dexcom Smart BasalSummary page 5…assification Class II, 21 CFR 862.1358, Product Code: QRX, Class II, 21 CFR 868.1890, Product Code: NDC. Predicate Devices DexCom Smart Basal K252818 Reference Device: DreaMed endo.digital platform (K232722)… | 2025 |
| † | K232722 | endo.digital Platform | 2023 |
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 8 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 6 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. 2026, 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?
MODI insulin dose calculator is software intended for the management of type 2 diabetes in persons aged 18 years and older requiring long-acting insulin with or without rapid-acting insulin injections. MODI insulin dose calculator calculates a dose of basal (long-acting) insulin with or without a dose of bolus (rapid-acting for meal and correction) insulin based on glucose measurements from an iCGM (Integrated Continuous Glucose Monitor) and insulin delivery data (i.e. time of dose with or without amount of dose). MODI insulin dose calculator intended for single patient, home use and requires a prescription by a healthcare provider.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260062: MODI System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260062
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026