510(k) K240309 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Tandem Mobi insulin pump with interoperable technology
| Applicant | Tandem Diabetes Care, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 21, 2024 |
| Received | Feb 2, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240309
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2026 | Tandem Diabetes Care, Inc. Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081, 1014801, 1014811, 1014813, 1014936, 1016911, 1016912, 1016913, 1016914, 1018075, 1018 Open, Classified |
QFG | None listed |
| Nov 5, 2025 | Tandem Diabetes Care, Inc. Tandem Mobi Insulin Pump:
Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism Open, Classified |
QFG | None listed |
| Oct 23, 2025 | Tandem Diabetes Care, Inc. t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor;
Tandem Mobi insulin pump with Interop Open, Classified |
QFG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.