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FDA 510(k)

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater

K-Number: K162080 · 2016-10-25

ApplicantTandem Diabetes Care, Inc.
Decision Date2016-10-25
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater is the device name listed in this FDA 510(k) record. The listed applicant is Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2016-10-25 under 510(k) number K162080. 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 t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater?

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater is a medical device that received FDA 510(k) clearance on 2016-10-25. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K162080.

When did t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater receive FDA 510(k) clearance?

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater received FDA 510(k) clearance on 2016-10-25, under 510(k) number K162080.

Who is the listed applicant for t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater?

The FDA 510(k) record lists Tandem Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater?

The FDA product code for t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater 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.

NCT06024928Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 DiabetesCOMPLETEDNCT05014789Control-IQ Technology 2.0 Adult and Adolescent Feasibility StudyCOMPLETEDNCT05785832A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 DiabetesCOMPLETEDNCT07325461Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 DiabetesCOMPLETEDNCT04414280The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMsACTIVE_NOT_RECRUITINGNCT06880835Effect of Inhaled Technosphere Insulin vs RAA Insulin on Exercise-Induced Hypoglycemia in Adults With T1D Using Automated Insulin DeliveryRECRUITING

Other records listing Tandem Diabetes Care, 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.

K260429Control-IQ+ technologyK253074Tandem Mobi insulin pump with interoperable technologyK250792t:slim X2 insulin pump with interoperable technologyK251854SteadiSet infusion setK250798Control-IQ+ technologyK243823Control-IQ+ technology

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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 CorporationK210714Extended ReservoirMedtronic Minimed, Inc.K211575Omnipod® 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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