Continuous Glucose Monitor Informed Insulin Dose Calculator
The Continuous Glucose Monitor Informed Insulin Dose Calculator is a software device that uses continuous glucose monitor (CGM) values and other relevant patient information to calculate suggested insulin doses for diabetes management. It is designed to assist patients and clinicians in making more precise and timely insulin dosing decisions. Classified as FDA Class 2 under regulation 862.1358, it requires 510(k) clearance in the Clinical Chemistry specialty. The device is not an implant and not life-sustaining.
Research product code QRX in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- QRX
- Device Class
- FDA class 2
- Regulation Number
- 862.1358
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252818 | Dexcom Smart Basal | Nov 18, 2025 | Substantially Equivalent | Dexcom, Inc. |
| K231824 | SmartBolus Calculator | Oct 18, 2023 | Substantially Equivalent | Insulet Corporation |
| K222888 | BlueStar CGM insulin dose calculator | Aug 11, 2023 | Substantially Equivalent | Welldoc, Inc. |
| K222239 | SmartBolus Calculator | Aug 19, 2022 | Substantially Equivalent | Insulet Corporation |
| K203772 | Omnipod 5 SmartBolus Calculator | Jan 27, 2022 | Substantially Equivalent | Insulet Corporation |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.