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FDA 510(k)

SmartGuard Technology; Predictive Low Glucose Technology

K-Number: K253701 · 2026-02-03

ApplicantMedtronic Minimed
Decision Date2026-02-03
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. It received FDA 510(k) clearance on 2026-02-03 under 510(k) number K253701. 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 2026-02-03. The listed applicant is Medtronic Minimed. The 510(k) number is K253701.

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 2026-02-03, under 510(k) number K253701.

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

The FDA 510(k) record lists Medtronic Minimed 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)RECRUITINGNCT07227805Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS)RECRUITINGNCT07228117GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With DiabetesRECRUITINGNCT07408141MiniMed Fit Payload Wear StudyCOMPLETEDNCT07675161MiniMed Fit Payload Wear Pediatric StudyRECRUITING

Other records listing Medtronic Minimed as applicant

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.

PMA P160017Automated insulin dosing device system, single hormonal controlPMA P250012Sensor, Glucose, Invasive, Component of automated insulin delivery systemPMA P160007Sensor, glucose, invasivePMA P150001Automated insulin dosing , threshold suspendK261962SmartGuard Technology; Predictive Low Glucose TechnologyK253743MiniMed Flex pump

View all 19 devices →

Related Devices (Code: QJI)

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.

K261962SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic MiniMedK261461Omnipod 6 algorithmInsulet CorporationK260429Control-IQ+ technologyTandem Diabetes Care, Inc.K253585SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc.K251152DBLG2DiabeloopK251779Omnipod 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.

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