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FDA 510(k)

SmartGuard technology; Predictive Low Glucose technology

K-Number: K253585 · 2026-01-14

ApplicantMedtronic Minimed, Inc.
Decision Date2026-01-14
Product CodeQJI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SmartGuard technology; Predictive Low Glucose technology is a medical device manufactured by Medtronic Minimed, Inc.. It received FDA 510(k) clearance on 2026-01-14 under approval number K253585. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartGuard technology; Predictive Low Glucose technology?

SmartGuard technology; Predictive Low Glucose technology is a medical device that received FDA 510(k) clearance on 2026-01-14. It is manufactured by Medtronic Minimed, Inc.. The 510(k) number is K253585.

When was SmartGuard technology; Predictive Low Glucose technology approved by the FDA?

SmartGuard technology; Predictive Low Glucose technology received FDA 510(k) clearance on 2026-01-14, under approval number K253585.

What company makes SmartGuard technology; Predictive Low Glucose technology?

SmartGuard technology; Predictive Low Glucose technology is manufactured by Medtronic Minimed, Inc..

What is the FDA product code for SmartGuard technology; Predictive Low Glucose technology?

The FDA product code for SmartGuard technology; Predictive Low Glucose technology is QJI.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT03288207 Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT06124196 Wearable Technology to Evaluate Hyperglycemia and HRV in DMD RECRUITING NCT05720377 Evaluation of Exercise Application Technology in Adolescents WITHDRAWN

Related PubMed Literature

PMID: 41964171 Journal of diabetes science and technology (2026)

Other Devices by Medtronic Minimed, Inc.

K210714Extended Reservoir K251217SmartGuard technology; Predictive Low Glucose technology K251032MiniMed 780G insulin pump K253743MiniMed Flex pump K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) PMA P160017Automated insulin dosing device system, single hormonal control

View all 8 devices →

Related Devices (Code: QJI)

DEN190034Control-IQ TechnologyTandem Diabetes Care, Inc. K200467Control-IQ TechnologyTandem Diabetes Care, Inc. K220394SmartAdjust(TM) technologyInsulet Corporation K203774SmartAdjust technologyInsulet Corporation K232382Control-IQ TechnologyTandem Diabetes Care, Inc. K232224iLet® Dosing Decision SoftwareBeta Bionics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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