FDA Product Code
FDA Product Code QJI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1356
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261896 | iOS CamAPS FX | CamDiab | 2026-09-16 | Traditional | PDF ↗ |
| K262763 | iLet Dosing Decision Software | Beta Bionics, Inc. | 2026-09-11 | Traditional | PDF ↗ |
| K261962 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic MiniMed | 2026-07-09 | Special | PDF ↗ |
| K261461 | Omnipod 6 algorithm | Insulet Corporation | 2026-06-29 | Traditional | PDF ↗ |
| K260429 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2026-04-24 | Traditional | PDF ↗ |
| K253701 | SmartGuard Technology; Predictive Low Glucose Technology | Medtronic Minimed | 2026-02-03 | Traditional | PDF ↗ |
| K253585 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | 2026-01-14 | Traditional | PDF ↗ |
| K251152 | DBLG2 | Diabeloop | 2025-12-19 | Traditional | PDF ↗ |
| K251779 | Omnipod 5 algorithm | Insulet Corporation | 2025-12-03 | Traditional | PDF ↗ |
| K251217 | SmartGuard technology; Predictive Low Glucose technology | Medtronic Minimed, Inc. | 2025-08-29 | Traditional | PDF ↗ |
| K250798 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2025-05-21 | Traditional | PDF ↗ |
| K243823 | Control-IQ+ technology | Tandem Diabetes Care, Inc. | 2025-02-24 | Traditional | PDF ↗ |
| K241777 | SmartAdjust Technology | Insulet Corporation | 2024-08-26 | Traditional | PDF ↗ |
| K232741 | SmartAdjust(TM) technology | Insulet Corporation | 2024-05-29 | Traditional | PDF ↗ |
| K232603 | CamAPS FX | Camdiab , Ltd. | 2024-05-23 | Traditional | PDF ↗ |
| K234055 | DEKA Loop | Deka Research and Development | 2024-03-13 | Traditional | PDF ↗ |
| K232382 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2023-11-03 | Traditional | PDF ↗ |
| K232224 | iLet® Dosing Decision Software | Beta Bionics, Inc. | 2023-09-22 | Traditional | PDF ↗ |
| K220916 | iLet® Dosing Decision Software | Beta Bionics, Inc. | 2023-05-19 | Traditional | PDF ↗ |
| K203689 | Tidepool Loop | Tidepool Project | 2023-01-23 | Traditional | PDF ↗ |
| K220394 | SmartAdjust(TM) technology | Insulet Corporation | 2022-08-19 | Traditional | PDF ↗ |
| K203774 | SmartAdjust technology | Insulet Corporation | 2022-01-27 | Traditional | PDF ↗ |
| K200467 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2020-06-16 | Traditional | PDF ↗ |
| DEN190034 | Control-IQ Technology | Tandem Diabetes Care, Inc. | 2019-12-13 | Direct | — |
Product code QJI · Class II · Clinical Chemistry. Data: openFDA.