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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 / K261360

510(k) cleared

EasyCare Tx 2

Resmed Corp · Aug 27, 2026 · K261360

FDA cleared the EasyCare Tx 2 from Resmed Corp on Aug 27, 2026 under K261360, 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 Apr 24, 2026. The decision came 125 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Resmed Corp has 5 other decisions in the tracker over the last 12 months: K253553 (Orion), K254104 (ResScan Essentials), K251889 (myAir), K251661 (Mariana Minerva; Mariana Nimbus).

Questions & Answers

What did FDA clear under K261360?

K261360 is the FDA 510(k) for EasyCare Tx 2, submitted by Resmed Corp. FDA's decision date was Aug 27, 2026, under product code MOD (Accessory To Continuous Ventilator (Respirator)).

Who makes the EasyCare Tx 2?

Resmed Corp, based in San Diego, CA, is the applicant of record for K261360.

How long did the K261360 review take?

FDA received the submission on Apr 24, 2026 and issued its decision on Aug 27, 2026, 125 days later.

← All decisions in August 2026

Sources