510(k) K250792 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
t:slim X2 insulin pump with interoperable technology
| Applicant | Tandem Diabetes Care, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 24, 2025 |
| Received | Mar 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250792
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2026 | Tandem Diabetes Care, Inc. Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, Open, Classified |
QFG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.