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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / August 2026 / DEN250049

510(k) cleared

Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System

Abbott Diabetes Care · Aug 25, 2026 · DEN250049

FDA cleared the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System from Abbott Diabetes Care on Aug 25, 2026 under DEN250049, a direct 510(k). The device falls under product code SJD, Integrated Continuous Glucose Ketone Monitoring System, regulated at 21 CFR 862.1354 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Sep 29, 2025. The decision came 330 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Abbott Diabetes Care in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250049?

DEN250049 is the FDA 510(k) for Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, submitted by Abbott Diabetes Care. FDA's decision date was Aug 25, 2026, under product code SJD ( Integrated Continuous Glucose Ketone Monitoring System).

Who makes the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System?

Abbott Diabetes Care, based in Alameda, CA, is the applicant of record for DEN250049.

How long did the DEN250049 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Aug 25, 2026, 330 days later.

← All decisions in August 2026