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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K251889

510(k) cleared

myAir

Resmed Corp · Apr 8, 2026 · K251889

FDA cleared the myAir from Resmed Corp on Apr 8, 2026 under K251889, a traditional 510(k). The device falls under product code MNS, Ventilator, Continuous, Non-Life-Supporting, regulated at 21 CFR 868.5895 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jun 20, 2025. The decision came 292 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Resmed Corp has 4 other decisions in the tracker over the last 12 months: K253553 (Orion), K254104 (ResScan Essentials), K251661 (Mariana Minerva; Mariana Nimbus), K251657 (Personalized Therapy Comfort Settings (PTCS)).

Questions & Answers

What did FDA clear under K251889?

K251889 is the FDA 510(k) for myAir, submitted by Resmed Corp. FDA's decision date was Apr 8, 2026, under product code MNS (Ventilator, Continuous, Non-Life-Supporting).

Who makes the myAir?

Resmed Corp, based in San Diego, CA, is the applicant of record for K251889.

How long did the K251889 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Apr 8, 2026, 292 days later.

← All decisions in April 2026

Sources