# K251217: SmartGuard technology; Predictive Low Glucose technology

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed, Inc.
- Decided: Aug 29, 2025 after 130 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: 3 generations back to DEN190034 (2019). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 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 6.

## Most influential descendants
- K253701: SmartGuard Technology; Predictive Low Glucose Technology (2026), 1 descendant of its own
- K261962: SmartGuard Technology; Predictive Low Glucose Technology (2026), 0 descendants of its own
- K253585: SmartGuard technology; Predictive Low Glucose technology (2026), 0 descendants of its own

## Indications for use
SmartGuard technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGMs), and alternate controller enabled (ACE) pumps to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose values. SmartGuard technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older requiring insulin. SmartGuard technology is intended for single patient use and requires a prescription. Predictive Low Glucose technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGMs), and alternate controller enabled (ACE) pumps to automatically suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values. Predictive Low Glucose technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older requiring insulin. Predictive Low Glucose technology is intended for single patient use and requires a prescription.

Source page: https://510kreport.com/device/K251217
Methodology: https://510kreport.com/methodology