510(k) K222239
- Device
- SmartBolus Calculator
- Applicant
- Insulet Corporation
- 510(k) number
- K222239
- Product code
- QRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-08-19
- Date received
- 2022-07-26
- 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
- Alexander Hamad
- Address
- 100 Nagog Park Acton MA US 01720 01720
FDA Registration Numbers#
- 3014585508
- 3004753838
Source Documents#
Other 510(k) Records For Product Code QRX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252818 | Dexcom Smart Basal | Dexcom, Inc. | 2025-11-18 |
| K231824 | SmartBolus Calculator | Insulet Corporation | 2023-10-18 |
| K222888 | BlueStar CGM insulin dose calculator | Welldoc, Inc. | 2023-08-11 |
| K203772 | Omnipod 5 SmartBolus Calculator | Insulet Corporation | 2022-01-27 |
Legacy Summary#
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FDA Review#
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