510(k) K201214 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, Jun 4, 2020 |
| Received | May 5, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201214
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2026 | Tandem Diabetes Care, Inc. Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 0038915247 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 |
| Aug 27, 2025 | Tandem Diabetes Care, Inc. Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911;
t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808;
t: slim X2, Basal-IQ, mg/dl, REF: 1004219;
Pump, t: Open, Classified |
QFG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.