SmartBolus Calculator
FDA 510(k) K222239 · Insulet Corporation
510(k) numberK222239
Submission
- Device name
- SmartBolus Calculator
- Applicant
- Insulet Corporation
Acton, MA, US - Received
- July 26, 2022
- Decision date
- August 19, 2022
- 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 |
|---|---|---|---|
| K260062 | MODI SystemQRX · Traditional | DreaMed Diabetes, Ltd. | 09/08/2026SE |
| 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 |
| K203772 | Omnipod 5 SmartBolus CalculatorQRX · Traditional | Insulet Corporation | 01/27/2022SE |
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| K261461 | Omnipod 6 algorithmQJI · Traditional | 06/29/2026SE |
| K251779 | Omnipod 5 algorithmQJI · Traditional | 12/03/2025SE |
| K241777 | SmartAdjust TechnologyQJI · Traditional | 08/26/2024SE |
| K232741 | SmartAdjust(TM) technologyQJI · Traditional | 05/29/2024SE |
| K231826 | Omnipod 5 ACE PumpQFG · Traditional | 10/18/2023SE |
| K231824 | SmartBolus CalculatorQRX · Traditional | 10/18/2023SE |
| K223372 | Omnipod GO Insulin Delivery DeviceLZG · Traditional | 04/24/2023SE |
| K220394 | SmartAdjust(TM) technologyQJI · Traditional | 08/19/2022SE |
| K203774 | SmartAdjust technologyQJI · Traditional | 01/27/2022SE |
| K203772 | Omnipod 5 SmartBolus CalculatorQRX · Traditional | 01/27/2022SE |
Questions and answers
When was SmartBolus Calculator cleared by the FDA?
SmartBolus Calculator (K222239) received a 510(k) decision of Substantially Equivalent on August 19, 2022, 24 days after the submission was received.
What is the product code of K222239?
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.