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FDA 510(k)

Control-IQ Technology

K-Number: K200467 · 2020-06-16

ApplicantTandem Diabetes Care, Inc.
Decision Date2020-06-16
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 2020-06-16 under approval number K200467. 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 2020-06-16. It is manufactured by Tandem Diabetes Care, Inc.. The 510(k) number is K200467.

When was Control-IQ Technology approved by the FDA?

Control-IQ Technology received FDA 510(k) clearance on 2020-06-16, under approval number K200467.

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

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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 K201214t:slim X2 Insulin Pump with Interoperable Technology

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Related Devices (Code: QJI)

DEN190034Control-IQ TechnologyTandem Diabetes Care, Inc. K220394SmartAdjust(TM) technologyInsulet Corporation K203774SmartAdjust technologyInsulet Corporation K232382Control-IQ TechnologyTandem Diabetes Care, Inc. 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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