MODI System
FDA 510(k) K260062 · DreaMed Diabetes, Ltd.
510(k) numberK260062
Submission
- Device name
- MODI System
- Applicant
- DreaMed Diabetes, Ltd.
Petah Tikva, IL - Received
- January 8, 2026
- Decision date
- September 8, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QRX – Continuous Glucose Monitor Informed Insulin Dose Calculator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1358
- Specialty
- Clinical Chemistry
A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information.
Other 510(k)s with product code QRX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252818 | Dexcom Smart BasalQRX · Traditional | Dexcom, Inc. | 11/18/2025SE |
| K231824 | SmartBolus CalculatorQRX · Traditional | Insulet Corporation | 10/18/2023SE |
| K222888 | BlueStar CGM insulin dose calculatorQRX · Traditional | Welldoc, Inc. | 08/11/2023SE |
| K222239 | SmartBolus CalculatorQRX · Traditional | Insulet Corporation | 08/19/2022SE |
| K203772 | Omnipod 5 SmartBolus CalculatorQRX · Traditional | Insulet Corporation | 01/27/2022SE |
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Questions and answers
When was MODI System cleared by the FDA?
MODI System (K260062) received a 510(k) decision of Substantially Equivalent on September 8, 2026, 243 days after the submission was received.
What is the product code of K260062?
The FDA product code is QRX – Continuous Glucose Monitor Informed Insulin Dose Calculator, a Class II (moderate risk) device regulated under 21 CFR 862.1358.