Panels › Clinical Chemistry › Product code QJI · Class 2
Interoperable Automated Glycemic Controller
Regulation 862.1356
10510(k)s in 12 months (25 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QJI
| Company | 510(k)s | Recalls |
|---|---|---|
| Insulet Corporation | 6 | 0 |
| Tandem Diabetes Care, Inc. | 6 | 0 |
| Medtronic MiniMed | 4 | 0 |
| Beta Bionics, Inc. | 3 | 0 |
| CamDiab | 2 | 0 |
| Deka Research and Development | 2 | 0 |
| Diabeloop | 1 | 0 |
| Tidepool Project | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2026 | K262576 | twiist Loop Algorithm Deka Research and Development Corp. | QJI |
| Sep 16, 2026 | K261896 | iOS CamAPS FX CamDiab, GB | QJI |
| Sep 11, 2026 | K262763 | iLet Dosing Decision Software Beta Bionics, Inc. | QJI |
| Jul 9, 2026 | K261962 | SmartGuard Technology; Predictive Low Glucose Technology Medtronic MiniMed | QJI |
| Jun 29, 2026 | K261461 | Omnipod 6 algorithm Insulet Corporation | QJI |
| Apr 24, 2026 | K260429 | Control-IQ+ technology Tandem Diabetes Care, Inc. | QJI |
| Feb 3, 2026 | K253701 | SmartGuard Technology; Predictive Low Glucose Technology Medtronic Minimed | QJI |
| Jan 14, 2026 | K253585 | SmartGuard technology; Predictive Low Glucose technology Medtronic Minimed, Inc. | QJI |
| Dec 19, 2025 | K251152 | DBLG2 Diabeloop, FR | QJI |
| Dec 3, 2025 | K251779 | Omnipod 5 algorithm Insulet Corporation | QJI |
| Aug 29, 2025 | K251217 | SmartGuard technology; Predictive Low Glucose technology Medtronic Minimed, Inc. | QJI |
| May 21, 2025 | K250798 | Control-IQ+ technology Tandem Diabetes Care, Inc. | QJI |
| Feb 24, 2025 | K243823 | Control-IQ+ technology Tandem Diabetes Care, Inc. | QJI |
| Aug 26, 2024 | K241777 | SmartAdjust Technology Insulet Corporation | QJI |
| May 29, 2024 | K232741 | SmartAdjust(TM) technology Insulet Corporation | QJI |
| May 23, 2024 | K232603 | CamAPS FX Camdiab , Ltd., GB | QJI |
| Mar 13, 2024 | K234055 | DEKA Loop Deka Research and Development | QJI |
| Nov 3, 2023 | K232382 | Control-IQ Technology Tandem Diabetes Care, Inc. | QJI |
| Sep 22, 2023 | K232224 | iLet® Dosing Decision Software Beta Bionics, Inc. | QJI |
| May 19, 2023 | K220916 | iLet® Dosing Decision Software Beta Bionics, Inc. | QJI |
| Jan 23, 2023 | K203689 | Tidepool Loop Tidepool Project | QJI |
| Aug 19, 2022 | K220394 | SmartAdjust(TM) technology Insulet Corporation | QJI |
| Jan 27, 2022 | K203774 | SmartAdjust technology Insulet Corporation | QJI |
| Jun 16, 2020 | K200467 | Control-IQ Technology Tandem Diabetes Care, Inc. | QJI |
| Dec 13, 2019 | DEN190034 | Control-IQ Technology Tandem Diabetes Care, Inc. | QJI |
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