FDA Product Code
FDA Product Code QRX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1358
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260062 | MODI System | DreaMed Diabetes, Ltd. | 2026-09-08 | Traditional | PDF ↗ |
| K252818 | Dexcom Smart Basal | Dexcom, Inc. | 2025-11-18 | Traditional | PDF ↗ |
| K231824 | SmartBolus Calculator | Insulet Corporation | 2023-10-18 | Traditional | PDF ↗ |
| K222888 | BlueStar CGM insulin dose calculator | Welldoc, Inc. | 2023-08-11 | Traditional | PDF ↗ |
| K222239 | SmartBolus Calculator | Insulet Corporation | 2022-08-19 | Traditional | PDF ↗ |
| K203772 | Omnipod 5 SmartBolus Calculator | Insulet Corporation | 2022-01-27 | Traditional | PDF ↗ |
Product code QRX · Class II · Clinical Chemistry. Data: openFDA.