# K233044: Tandem Mobi insulin pump with interoperable technology

- Pathway: 510(k) (Special)
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Oct 5, 2023 after 10 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: 2 (1 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.
3 later devices descend 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)
- K223213: Tandem Mobi Insulin Pump with Interoperable Technology, Tandem Diabetes Care, Inc. (2023) Summary page 4.

## Most influential descendants
- K240309: Tandem Mobi insulin pump with interoperable technology (2024), 2 descendants of its own
- K241078: Tandem Mobi Insulin Pump with interoperable technology (2024), 1 descendant of its own
- 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 

## 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 six years of age and greater.

Source page: https://510kreport.com/device/K233044
Methodology: https://510kreport.com/methodology