# K241078: Tandem Mobi Insulin Pump with interoperable technology

- Pathway: 510(k) (Traditional)
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Jul 26, 2024 after 98 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: 4 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN180058 (2019). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240309: Tandem Mobi insulin pump with interoperable technology, Tandem Diabetes Care, Inc. (2024) Summary page 4.

## Most influential descendants
- K253074: Tandem Mobi insulin pump with interoperable technology (2025), 0 descendants of its own

## Recalls of this device
- Sep 23, 2026 · Not classified · Z-0316-2027: Tandem Diabetes Care, Inc. ( Tandem ) has identified that certain Tandem Mobi insulin pumps may generate false-positive occlusion alarms when no actual insulin flow obstruction is present. Investigati
- Oct 6, 2025 · Class I · Z-0427-2026: Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 
- Aug 5, 2025 · Class II · Z-0232-2026: A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may 
- Feb 27, 2025 · Class I · Z-1520-2025: 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 Tandem Mobi 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/K241078
Methodology: https://510kreport.com/methodology