510(k) K232380 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, Nov 3, 2023 |
| Received | Aug 8, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232380
| 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 |
| 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 |
| Sep 24, 2025 | Tandem Diabetes Care, Inc. t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) Open, Classified |
QFG | None listed |
| Apr 11, 2025 | Tandem Diabetes Care, Inc. t:slim X2 Insulin Pump with Interoperable Technology Open, Classified |
QFG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.