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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 / K253807

510(k) cleared

Valence InVent Xtend (CVG-4101-VXA)

Convergence Medical Sciences , Ltd. · Aug 20, 2026 · K253807

FDA cleared the Valence InVent Xtend (CVG-4101-VXA) from Convergence Medical Sciences , Ltd. on Aug 20, 2026 under K253807, a traditional 510(k). The device falls under product code MOD, Accessory To Continuous Ventilator (Respirator), regulated at 21 CFR 868.5895 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Nov 28, 2025. The decision came 265 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 Convergence Medical Sciences , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253807?

K253807 is the FDA 510(k) for Valence InVent Xtend (CVG-4101-VXA), submitted by Convergence Medical Sciences , Ltd.. FDA's decision date was Aug 20, 2026, under product code MOD (Accessory To Continuous Ventilator (Respirator)).

Who makes the Valence InVent Xtend (CVG-4101-VXA)?

Convergence Medical Sciences , Ltd., based in Calgary, is the applicant of record for K253807.

How long did the K253807 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Aug 20, 2026, 265 days later.

← All decisions in August 2026