# K232380: t:slim X2 Insulin Pump with Interoperable Technology

- Pathway: 510(k) (Traditional)
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Nov 3, 2023 after 87 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN180058 (2019). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
3 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203234: t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app), Tandem Diabetes Care, Inc. (2022) Summary page 5.

## Most influential descendants
- K251032: MiniMed 780G insulin pump (2025), 4 descendants of its own
- K253701: SmartGuard Technology; Predictive Low Glucose Technology (2026), 1 descendant of its own
- K261962: SmartGuard Technology; Predictive Low Glucose Technology (2026), 0 descendants of its own
- K253743: MiniMed Flex pump (2026), 0 descendants of its own
- K253470: MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) (2026), 0 descendants of its own

## Recalls of this device
- Jul 16, 2026 · Class II · Z-3330-2026: A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P)
- 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
- Jul 3, 2025 · Class II · Z-2621-2025: an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and s
- Feb 27, 2025 · Class I · Z-1519-2025: A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends w

## 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/K232380
Methodology: https://510kreport.com/methodology