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FDA 510(k)

SmartGuard technology; Predictive Low Glucose technology

K-Number: K251217 · 2025-08-29

ApplicantMedtronic Minimed, Inc.
Decision Date2025-08-29
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 2025-08-29 under approval number K251217. 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 2025-08-29. It is manufactured by Medtronic Minimed, Inc.. The 510(k) number is K251217.

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

SmartGuard technology; Predictive Low Glucose technology received FDA 510(k) clearance on 2025-08-29, under approval number K251217.

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.

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Other Devices by Medtronic Minimed, Inc.

K210714Extended Reservoir K251032MiniMed 780G insulin pump K253743MiniMed Flex pump K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) K253585SmartGuard technology; Predictive Low Glucose technology PMA P160017Automated insulin dosing device system, single hormonal control

View all 8 devices →

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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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