# K250792: t:slim X2 insulin pump with interoperable technology

- Pathway: 510(k) (Traditional)
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Sep 24, 2025 after 194 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN180058 (2019). 4 ancestors in all.
No later device cites it as a predicate yet.
3 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232380: t:slim X2 Insulin Pump with Interoperable Technology, Tandem Diabetes Care, Inc. (2023) Summary page 5.

## Recalls of this device
- Jan 30, 2026 · Class II · Z-1636-2026: The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when i

## Indications for use
The t:slim X2 Insulin Pump with Interoperable Technology (the Pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Pump is intended for single patient, home use and requires a prescription. The Pump is indicated for use in individuals 2 years of age and greater.

Source page: https://510kreport.com/device/K250792
Methodology: https://510kreport.com/methodology