Data / Medical devices / Interoperable Automated Glycemic Controller / United States
FDA-registered makers of Interoperable Automated Glycemic Controller in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Interoperable Automated Glycemic Controller (product code QJI). 9 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Interoperable Automated Glycemic Controller
- Product code
- QJI
- Country
- United States
Makers of Interoperable Automated Glycemic Controller in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 5 | April 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Minimed | Northridge, CA, United States | Manufacturer | 3 | February 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Manufacturer, Repackager or relabeler | 3 | November 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Tandem Diabetes Care, INC. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | November 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Deka Research & Development Corp. | Manchester, NH, United States | Specification developer | 2 | October 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Insulet Corporation | Acton, MA, United States | Complaint file establishment, Manufacturer | 2 | December 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Beta Bionics, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 1 | May 19, 2023 | 0 | 0 | 0 | api.fda.gov |
| Millyard Advanced Medical Products LLC | Manchester, NH, United States | Complaint file establishment, Manufacturer | 1 | March 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Millyard Advanced Medical Products LLC | Manchester, NH, United States | Manufacturer | 1 | March 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Merrimack Manufacturing | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.