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FDA 510(k)

InPen System App (MMT-8060 (iOS), MMT-8061 (Android))

K-Number: K242775 · 2024-11-12

ApplicantMedtronic Minimed
Decision Date2024-11-12
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed. It received FDA 510(k) clearance on 2024-11-12 under 510(k) number K242775. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InPen System App (MMT-8060 (iOS), MMT-8061 (Android))?

InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Medtronic Minimed. The 510(k) number is K242775.

When did InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) receive FDA 510(k) clearance?

InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) received FDA 510(k) clearance on 2024-11-12, under 510(k) number K242775.

Who is the listed applicant for InPen System App (MMT-8060 (iOS), MMT-8061 (Android))?

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 InPen System App (MMT-8060 (iOS), MMT-8061 (Android))?

The FDA product code for InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) is NDC.

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 StudyRECRUITINGNCT05515939Evaluating the InPen in Pediatric Type 1 DiabetesACTIVE_NOT_RECRUITING

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: NDC)

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.

K254102GlucommanderGlytec, LLCK260910EndoTool IV Cloud 1.0Glooko, Inc.K253512MiniMed Go AppMedtronic MinimedK253281UpDocUpdoc, Inc.K252104T1D1Comerge AGK241088EndoTool IV (3.1)Monarch Medical Technologies

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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