Panels › Clinical Chemistry › Product code QRX · Class 2
Continuous Glucose Monitor Informed Insulin Dose Calculator
Regulation 862.1358
2510(k)s in 12 months (6 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in QRX
| Company | 510(k)s | Recalls |
|---|---|---|
| Insulet Corporation | 3 | 2 |
| Dexcom, Inc. | 1 | 0 |
| DreaMed Diabetes, Ltd. | 1 | 0 |
| Welldoc, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 8, 2026 | K260062 | MODI System DreaMed Diabetes, Ltd., IL | QRX |
| Nov 18, 2025 | K252818 | Dexcom Smart Basal Dexcom, Inc. | QRX |
| Oct 18, 2023 | K231824 | SmartBolus Calculator Insulet Corporation | QRX |
| Aug 11, 2023 | K222888 | BlueStar CGM insulin dose calculator Welldoc, Inc. | QRX |
| Aug 19, 2022 | K222239 | SmartBolus Calculator Insulet Corporation | QRX |
| Jan 27, 2022 | K203772 | Omnipod 5 SmartBolus Calculator Insulet Corporation | QRX |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.