QRX — Continuous Glucose Monitor Informed Insulin Dose Calculator Class II
Classification Details
- Product Code
- QRX
- Device Class
- Class II
- Regulation Number
- 862.1358
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252818 | dexcom | Dexcom Smart Basal | November 18, 2025 |
| K231824 | insulet corporation | SmartBolus Calculator | October 18, 2023 |
| K222888 | welldoc | BlueStar CGM insulin dose calculator | August 11, 2023 |
| K222239 | insulet corporation | SmartBolus Calculator | August 19, 2022 |
| K203772 | insulet corporation | Omnipod 5 SmartBolus Calculator | January 27, 2022 |