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FDA 510(k)

MiniMed 780G insulin pump

K-Number: K251032 · 2025-07-01

ApplicantMedtronic Minimed, Inc.
Decision Date2025-07-01
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MiniMed 780G insulin pump is a medical device manufactured by Medtronic Minimed, Inc.. It received FDA 510(k) clearance on 2025-07-01 under approval number K251032. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiniMed 780G insulin pump?

MiniMed 780G insulin pump is a medical device that received FDA 510(k) clearance on 2025-07-01. It is manufactured by Medtronic Minimed, Inc.. The 510(k) number is K251032.

When was MiniMed 780G insulin pump approved by the FDA?

MiniMed 780G insulin pump received FDA 510(k) clearance on 2025-07-01, under approval number K251032.

What company makes MiniMed 780G insulin pump?

MiniMed 780G insulin pump is manufactured by Medtronic Minimed, Inc..

What is the FDA product code for MiniMed 780G insulin pump?

The FDA product code for MiniMed 780G insulin pump is QFG.

Related Clinical Trials

NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT07602036 Type 2 Diabetes and Pregnancy a Single-arm Interventional Study NOT_YET_RECRUITING NCT07228117 GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes RECRUITING NCT07401901 Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in Adults Living With Type 1 Diabetes NOT_YET_RECRUITING NCT05238142 In-Home Study With MiniMed™ 780G Pump Automated Control in Type 2-Evaluation of the AHCL System in Adults With Insulin-requiring Type 2 Diabetes COMPLETED

Other Devices by Medtronic Minimed, Inc.

K210714Extended Reservoir K251217SmartGuard technology; Predictive Low Glucose technology 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 →

Related Devices (Code: QFG)

K191679Omnipod DASH Insulin Management System with interoperable technologyInsulet Corporation DEN180058t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. K201214t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)Tandem Diabetes Care, Inc. K203768Omnipod 5 ACE Pump (Pod)Insulet Corporation K230545Inessa SystemTriple Jump Israel , Ltd.

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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