Not Cleared Direct

DEN250049 - Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System

DEN250049 · Abbott Diabetes Care · Chemistry device
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Aug 2026
Decision
330d
Days
-
Risk

DEN250049 is an FDA 510(k) submission (not cleared) for the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System.

Submitted by Abbott Diabetes Care (Alameda, US). The FDA issued a Not Cleared (DENG) decision on August 25, 2026 after a review of 330 days.

This device falls under the Chemistry FDA review panel. 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: Regulatory edge-case submission. High predicate equivalence gap. With 330 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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FDA 510(k) Submission Details - DEN250049

510(k) Number DEN250049 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 29, 2025
Decision Date August 25, 2026
Days to Decision 330 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
242d slower than avg
Panel avg: 88d · This submission: 330d
Pathway characteristics

SJD Device Classification - Class ,

Product Code SJD
Device Class -