BlueStar CGM insulin dose calculator
FDA 510(k) K222888 · Welldoc, Inc.
510(k) numberK222888
Submission
- Device name
- BlueStar CGM insulin dose calculator
- Applicant
- Welldoc, Inc.
Columbia, MD, US - Received
- September 23, 2022
- Decision date
- August 11, 2023
- 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 |
| K222239 | SmartBolus CalculatorQRX · Traditional | Insulet Corporation | 08/19/2022SE |
| K203772 | Omnipod 5 SmartBolus CalculatorQRX · Traditional | Insulet Corporation | 01/27/2022SE |
More from Insulet Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K230813 | BlueStar and BlueStar RxNDC · Traditional | 07/28/2023SE |
| K203434 | BlueStar RxNDC · Traditional | 09/08/2021SE |
| K193654 | BlueStar RxMRZ · Traditional | 04/07/2020SE |
| K190013 | WellDoc BlueStarMRZ · Traditional | 11/04/2019SE |
| K162532 | WellDoc BlueStar, WellDoc BlueStar RxMRZ · Traditional | 01/12/2017SE |
| K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemMRZ · Traditional | 11/22/2016SE |
| K141273 | Welldoc Diabetesmanager System and Diabetesmanager- RX SysteMRZ · Special | 07/08/2014SE |
| K120314 | Welldoc Diabetes Manager System and Diabetes Manager RX SystemMRZ · Special | 02/24/2012SE |
| K112370 | Welldoc Diabetes Manager System and Diabetes Manager RX SystemMRZ · Special | 10/14/2011SE |
| K100066 | Diabetesmanager System, Diabetesmanager-Rx System Model Version 1.1MRZ · Traditional | 07/15/2010SE |
Questions and answers
When was BlueStar CGM insulin dose calculator cleared by the FDA?
BlueStar CGM insulin dose calculator (K222888) received a 510(k) decision of Substantially Equivalent on August 11, 2023, 322 days after the submission was received.
What is the product code of K222888?
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.