510(k) K222888
- Device
- BlueStar CGM insulin dose calculator
- Applicant
- Welldoc, Inc.
- 510(k) number
- K222888
- Product code
- QRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-11
- Date received
- 2022-09-23
- Regulation
- 862.1358
- Classification name
- Continuous Glucose Monitor Informed Insulin Dose Calculator
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ian Cadieux
- Address
- 10221 Wincopin Cir., Suite 150 Columbia MD US 21044 21044
FDA Registration Numbers#
- 3014585508
- 3004753838
Source Documents#
Other 510(k) Records For Product Code QRX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260062 | MODI System | DreaMed Diabetes, Ltd. | 2026-09-08 |
| K252818 | Dexcom Smart Basal | Dexcom, Inc. | 2025-11-18 |
| K231824 | SmartBolus Calculator | Insulet Corporation | 2023-10-18 |
| K222239 | SmartBolus Calculator | Insulet Corporation | 2022-08-19 |
| K203772 | Omnipod 5 SmartBolus Calculator | Insulet Corporation | 2022-01-27 |