WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

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 review panel was Unknown.

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.

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