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FDA 510(k)

Control-IQ Technology

K-Number: K232382 · 2023-11-03

ApplicantTandem Diabetes Care, Inc.
Decision Date2023-11-03
Product CodeQJI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Control-IQ Technology is a medical device manufactured by Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2023-11-03 under approval number K232382. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Control-IQ Technology?

Control-IQ Technology is a medical device that received FDA 510(k) clearance on 2023-11-03. It is manufactured by Tandem Diabetes Care, Inc.. The 510(k) number is K232382.

When was Control-IQ Technology approved by the FDA?

Control-IQ Technology received FDA 510(k) clearance on 2023-11-03, under approval number K232382.

What company makes Control-IQ Technology?

Control-IQ Technology is manufactured by Tandem Diabetes Care, Inc..

What is the FDA product code for Control-IQ Technology?

The FDA product code for Control-IQ Technology is QJI.

Related Clinical Trials

NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT07095894 A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control NOT_YET_RECRUITING NCT06124196 Wearable Technology to Evaluate Hyperglycemia and HRV in DMD RECRUITING NCT07601997 Safety and Feasibility of Transcatheter Injectable Hydrogel in Acute STEMI Reperfusion Injury (REFINE Study) NOT_YET_RECRUITING NCT07328555 Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children ACTIVE_NOT_RECRUITING NCT06938412 Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation RECRUITING

Related PubMed Literature

PMID: 40246728 [Analysis of the Core Principles and Key Design and Development Control Factors of Two Typical Point-of-Care Testing Technologies]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by Tandem Diabetes Care, Inc.

K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater K160056t:slim Insulin Delivery System 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

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Related Devices (Code: QJI)

DEN190034Control-IQ TechnologyTandem Diabetes Care, Inc. K200467Control-IQ TechnologyTandem Diabetes Care, Inc. K220394SmartAdjust(TM) technologyInsulet Corporation K203774SmartAdjust technologyInsulet Corporation K232224iLet® Dosing Decision SoftwareBeta Bionics, Inc. K220916iLet® Dosing Decision SoftwareBeta Bionics, 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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