# DEN190034: Control-IQ Technology

- Pathway: De Novo (Direct)
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Dec 13, 2019 after 151 days
- Product code: QJI (Interoperable Automated Glycemic Controller)
- Device class: 2
- Regulation: 21 CFR 862.1356
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 2 cite it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K200467: Control-IQ Technology (2020), 15 descendants of its own
- K232382: Control-IQ Technology (2023), 7 descendants of its own
- K251217: SmartGuard technology; Predictive Low Glucose technology (2025), 3 descendants of its own
- K243823: Control-IQ+ technology (2025), 2 descendants of its own
- K220916: iLet® Dosing Decision Software (2023), 2 descendants of its own

## 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 14 years of age and greater. Control-IQ technology is intended for single patient use and requires a prescription. Control-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin.

Source page: https://510kreport.com/device/DEN190034
Methodology: https://510kreport.com/methodology