# K253585: SmartGuard technology; Predictive Low Glucose technology

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed, Inc.
- Decided: Jan 14, 2026 after 58 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: 4 generations back to DEN190034 (2019). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251217: SmartGuard technology; Predictive Low Glucose technology, Medtronic Minimed, Inc. (2025) Summary page 6.

## 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, and of Type 2 diabetes mellitus in persons 18 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, and of Type 2 diabetes mellitus in persons 18 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/K253585
Methodology: https://510kreport.com/methodology