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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2025 | Insulet Corporation The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneous Open, Classified |
QRX | K231826 |
| Jun 24, 2025 | Insulet Corporation Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP.
Software Version: all
Product Description: The Omnipod 5 iOS App software is available to download
Open, Classified |
QRX | K231826 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.