# K203774: SmartAdjust technology

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Jan 27, 2022 after 400 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
Longest line of descent: 2 generations back to DEN190034 (2019). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200467: Control-IQ Technology, Tandem Diabetes Care, Inc. (2020) Summary page 4.

## Indications for use
SmartAdjust technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. SmartAdjust technology is intended for the management of type 1 diabetes mellitus in persons 6 years of age and older. SmartAdjust technology is intended for single patient use and requires a prescription.

Source page: https://510kreport.com/device/K203774
Methodology: https://510kreport.com/methodology