FDA 510(k)

SmartGuard technology; Predictive Low Glucose technology

K-Number: K253585 · 2026-01-14

Decision Date2026-01-14

Product CodeQJI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SmartGuard technology; Predictive Low Glucose technology is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed, Inc.. It received FDA 510(k) clearance on 2026-01-14 under 510(k) 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. The listed applicant is Medtronic Minimed, Inc.. The 510(k) number is K253585.

When did SmartGuard technology; Predictive Low Glucose technology receive FDA 510(k) clearance?

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

Who is the listed applicant for SmartGuard technology; Predictive Low Glucose technology?

The FDA 510(k) record lists Medtronic Minimed, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06739811Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes (CIP347)RECRUITING NCT07227805Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS)RECRUITING NCT07228117GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With DiabetesRECRUITING NCT07408141MiniMed Fit Payload Wear StudyCOMPLETED NCT07675161MiniMed Fit Payload Wear Pediatric StudyRECRUITING

Other records listing Medtronic Minimed, Inc. as applicant

PMA P160017Automated insulin dosing device system, single hormonal control PMA P250012Sensor, Glucose, Invasive, Component of automated insulin delivery system PMA P160007Sensor, glucose, invasive PMA P150001Automated insulin dosing , threshold suspend K261962SmartGuard Technology; Predictive Low Glucose Technology K253743MiniMed Flex pump

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Related Devices (Code: QJI)

K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMed K261461Omnipod 6 algorithmInsulet Corporation K260429Control-IQ+ technologyTandem Diabetes Care, Inc.K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed K251152DBLG2Diabeloop K251779Omnipod 5 algorithmInsulet Corporation

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.