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FDA 510(k)

MiniMed Flex pump

K-Number: K253743 · 2026-03-12

ApplicantMedtronic Minimed, Inc.
Decision Date2026-03-12
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MiniMed Flex pump 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 2026-03-12 under 510(k) number K253743. 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 Flex pump?

MiniMed Flex pump is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Medtronic Minimed, Inc.. The 510(k) number is K253743.

When did MiniMed Flex pump receive FDA 510(k) clearance?

MiniMed Flex pump received FDA 510(k) clearance on 2026-03-12, under 510(k) number K253743.

Who is the listed applicant for MiniMed Flex pump?

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 MiniMed Flex pump?

The FDA product code for MiniMed Flex pump is QFG.

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.

NCT07408141MiniMed Fit Payload Wear StudyCOMPLETEDNCT07675161MiniMed Fit Payload Wear Pediatric StudyRECRUITINGNCT04414280The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMsACTIVE_NOT_RECRUITINGNCT07720388Supporting Medtronic 780G Insulin Pump Adoption in Latino Patients: A Spanish - Language Training InitiativeNOT_YET_RECRUITINGNCT06739811Clinical 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)RECRUITING

Other records listing Medtronic Minimed, Inc. 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 TechnologyK253701SmartGuard Technology; Predictive Low Glucose Technology

View all 19 devices →

Related Devices (Code: QFG)

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.

K261672twiist Automated Insulin Delivery (AID) SystemDeka Research and DevelopmentK253976iLet ACE PumpBeta Bionics, Inc.K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.K253074Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.K252770iLet ACE PumpBeta Bionics, Inc.K250792t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, 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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