Data / Medical devices / Alternate Controller Enabled Insulin Infusion Pump / United States
FDA-registered makers of Alternate Controller Enabled Insulin Infusion Pump in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Alternate Controller Enabled Insulin Infusion Pump (product code QFG). 11 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Alternate Controller Enabled Insulin Infusion Pump
- Product code
- QFG
- Country
- United States
Makers of Alternate Controller Enabled Insulin Infusion Pump 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, Remanufacturer, Repackager or relabeler, Specification developer | 9 | November 6, 2025 | 0 | 9 | 4 | api.fda.gov |
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 7 | July 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Tandem Diabetes Care, INC. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 7 | July 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Manufacturer | 6 | July 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Deka Research & Development Corp. | Manchester, NH, United States | Specification developer | 4 | June 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Minimed | Northridge, CA, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 3 | March 12, 2026 | 0 | 5 | 0 | api.fda.gov |
| Beta Bionics, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 2 | October 21, 2026 | 0 | 3 | 0 | api.fda.gov |
| Insulet Corporation | Acton, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | October 18, 2023 | 0 | 5 | 3 | api.fda.gov |
| Millyard Advanced Medical Products LLC | Manchester, NH, United States | Complaint file establishment, Manufacturer | 2 | April 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Juncos | Juncos, PR, United States | Manufacturer | 1 | July 1, 2025 | 0 | 0 | 0 | api.fda.gov |
| Millyard Advanced Medical Products LLC | Manchester, NH, United States | Manufacturer | 1 | April 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Merrimack Manufacturing | Manchester, NH, United States | Contract manufacturer | 0 | 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.