# K243823: Control-IQ+ technology

- Pathway: 510(k) (Traditional)
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Feb 24, 2025 after 74 days
- Product code: QJI (Interoperable Automated Glycemic Controller)
- Device class: 2
- Regulation: 21 CFR 862.1356
- 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: 3 generations back to DEN190034 (2019). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232382: Control-IQ Technology, Tandem Diabetes Care, Inc. (2023) Summary page 5.

## Most influential descendants
- K250798: Control-IQ+ technology (2025), 1 descendant of its own
- K260429: Control-IQ+ technology (2026), 0 descendants of its own

## 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
Control-IQ+ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ+ technology is intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and of Type 2 diabetes mellitus in persons 18 years of age and greater. Control-IQ+ technology is intended for single patient use and requires a prescription.

Source page: https://510kreport.com/device/K243823
Methodology: https://510kreport.com/methodology