Not Cleared Direct

Control-IQ Technology (DEN190034) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN190034 · Tandem Diabetes Care, Inc. · Chemistry device
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Dec 2019
Decision
151d
Days
Class 2
Risk

DEN190034 is an FDA 510(k) submission (not cleared) for the Control-IQ Technology. Classified as Interoperable Automated Glycemic Controller (product code QJI), Class II - Special Controls.

Submitted by Tandem Diabetes Care, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on December 13, 2019 after a review of 151 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1356 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Chemistry review framework.

View all Tandem Diabetes Care, Inc. devices

Submission Details

510(k) Number DEN190034 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 15, 2019
Decision Date December 13, 2019
Days to Decision 151 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 88d · This submission: 151d
Pathway characteristics

Device Classification

Product Code QJI Interoperable Automated Glycemic Controller
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1356
Definition An Interoperable Automated Glycemic Controller Is A Device Intended To Automatically Calculate Drug Doses Based On Inputs Such As Glucose And Other Relevant Physiological Parameters, And To Command The Delivery Of Such Drug Doses From A Connected Infusion Pump. Interoperable Automated Glycemic Controllers Are Designed To Reliably And Securely Communicate With Digitally Connected Devices To Allow Drug Delivery Commands To Be Sent, Received, Executed, And Confirmed. Interoperable Automated Glycemic Controllers Are Intended To Be Used In Conjunction With Digitally Connected Devices For The Purpose Of Maintaining Glycemic Control.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

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