# K253701: SmartGuard Technology; Predictive Low Glucose Technology

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Feb 3, 2026 after 71 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: 12 generations back to K010362 (2001). 28 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 30 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 5.
- K251032: MiniMed 780G insulin pump, Medtronic Minimed, Inc. (2025) Summary page 5.

## Most influential descendants
- K261962: 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 (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose (SG) values. SmartGuard technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older, and 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 (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values. Predictive Low Glucose technology suspends and resumes insulin delivery in Manual mode. Manual mode contains a bolus calculator that calculates an insulin dose based on user-entered data. Predictive Low Glucose technology is intended for the management of type 1 diabetes mellitus in persons 7 years of age and older, and 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/K253701
Methodology: https://510kreport.com/methodology