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FDA 510(k)

t:slim Insulin Delivery System

K-Number: K160056 · 2016-07-25

ApplicantTandem Diabetes Care, Inc.
Decision Date2016-07-25
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

t:slim Insulin Delivery System is a medical device manufactured by Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2016-07-25 under approval number K160056. 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:slim Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2016-07-25. It is manufactured by Tandem Diabetes Care, Inc.. The 510(k) number is K160056.

When was t:slim Insulin Delivery System approved by the FDA?

t:slim Insulin Delivery System received FDA 510(k) clearance on 2016-07-25, under approval number K160056.

What company makes t:slim Insulin Delivery System?

t:slim Insulin Delivery System is manufactured by Tandem Diabetes Care, Inc..

What is the FDA product code for t:slim Insulin Delivery System?

The FDA product code for t:slim Insulin Delivery System is LZG.

Related Clinical Trials

NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING 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

Related PubMed Literature

PMID: 38767890 Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Journal of the American Medical Informatics Association : JAMIA (2024) PMID: 37873612 A European regulatory pathway for Tidepool loop following clearance in the United States? Diabetic medicine : a journal of the British Diabetic Association (2024)

Other Devices by Tandem Diabetes Care, Inc.

K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater DEN190034Control-IQ Technology DEN180058t:slim X2 insulin pump with interoperable technology K200467Control-IQ Technology K201214t:slim X2 Insulin Pump with Interoperable Technology

View all 22 devices →

Related Devices (Code: LZG)

K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. K160252OmniPod Insulin Management SystemInsulet Corporation K162296OmniPod Insulin Management SystemInsulet Corporation K180045Omnipod DASH Insulin Management SystemInsulet Corporation K192659Omnipod 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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