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FDA 510(k)

Extended Reservoir

K-Number: K210714 · 2022-04-06

ApplicantMedtronic Minimed, Inc.
Decision Date2022-04-06
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Extended Reservoir 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 2022-04-06 under 510(k) number K210714. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Extended Reservoir?

Extended Reservoir is a medical device that received FDA 510(k) clearance on 2022-04-06. The listed applicant is Medtronic Minimed, Inc.. The 510(k) number is K210714.

When did Extended Reservoir receive FDA 510(k) clearance?

Extended Reservoir received FDA 510(k) clearance on 2022-04-06, under 510(k) number K210714.

Who is the listed applicant for Extended Reservoir?

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 Extended Reservoir?

The FDA product code for Extended Reservoir is LZG.

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, 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 TechnologyK253743MiniMed Flex pump

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Related Devices (Code: LZG)

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.

K253534Pivot Insulin Delivery SystemModular MedicalK240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet CorporationK192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet 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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