Not Cleared Direct

DEN180058 - t:slim X2 insulin pump with interoper...

DEN180058 is the FDA 510(k) submission for t:slim X2 insulin pump with interoper... by Tandem Diabetes Care, Inc.. It is a Class 2 Chemistry device (product code QFG) cleared through the Direct 510(k) pathway after a 108-day FDA review.

DEN180058 · Tandem Diabetes Care, Inc. · Chemistry device
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Feb 2019
Decision
108d
Days
Class 2
Risk

DEN180058 is an FDA 510(k) submission (not cleared) for the t:slim X2 insulin pump with interoperable technology. Classified as Alternate Controller Enabled Insulin Infusion Pump (product code QFG), Class II - Special Controls.

Submitted by Tandem Diabetes Care, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on February 14, 2019 after a review of 108 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 880.5730 - 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 DEN180058 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 29, 2018
Decision Date February 14, 2019
Days to Decision 108 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics

Device Classification

Product Code QFG Alternate Controller Enabled Insulin Infusion Pump
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5730
Definition An Alternate Controller Enabled Insulin Infusion Pump (ace Insulin Pump) Is A Device Intended For The Infusion Of Insulin Into A Patient. The Ace Insulin Pump May Include Basal And Bolus Drug Delivery At Set Or Variable Rates. Ace Insulin Pumps Are Designed To Reliably And Securely Communicate With External Devices, Such As Automated Insulin Dosing Systems, To Allow Insulin Delivery Commands To Be Received, Executed, And Confirmed. Ace Insulin Pumps Are Intended To Be Used Both Alone And In Conjunction With Digitally Connected Medical Devices For The Purpose Of Insulin Delivery.
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.