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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 / February 2026 / K251661

510(k) cleared

Mariana Minerva; Mariana Nimbus

Resmed Pty , Ltd. · Feb 23, 2026 · K251661

FDA cleared the Mariana Minerva; Mariana Nimbus from Resmed Pty , Ltd. on Feb 23, 2026 under K251661, 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 May 30, 2025. The decision came 269 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Resmed Pty , Ltd. has 4 other decisions in the tracker over the last 12 months: K253553 (Orion), K254104 (ResScan Essentials), K251889 (myAir), K251657 (Personalized Therapy Comfort Settings (PTCS)).

Questions & Answers

What did FDA clear under K251661?

K251661 is the FDA 510(k) for Mariana Minerva; Mariana Nimbus, submitted by Resmed Pty , Ltd.. FDA's decision date was Feb 23, 2026, under product code MNS (Ventilator, Continuous, Non-Life-Supporting).

Who makes the Mariana Minerva; Mariana Nimbus?

Resmed Pty , Ltd., based in Bella Vista, is the applicant of record for K251661.

How long did the K251661 review take?

FDA received the submission on May 30, 2025 and issued its decision on Feb 23, 2026, 269 days later.

← All decisions in February 2026

Sources