QRX
5 FDA 510(k) clearances · Product code
119 daysmedian time to decision
400 days90th percentile
5clearances measured
FDA profile
- Official device name
- Continuous Glucose Monitor Informed Insulin Dose Calculator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1358
- Medical specialty
- Clinical Chemistry
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Dexcom Smart Basal (K252818) | Dexcom, Inc. | 2025-11-18 |
| SmartBolus Calculator (K231824) | Insulet Corporation | 2023-10-18 |
| BlueStar CGM insulin dose calculator (K222888) | Welldoc, Inc. | 2023-08-11 |
| SmartBolus Calculator (K222239) | Insulet Corporation | 2022-08-19 |
| Omnipod 5 SmartBolus Calculator (K203772) | Insulet Corporation | 2022-01-27 |
Track QRX automatically
Every clearance here is in the API, with alerts when new ones post.