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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 / June 2026 / K253553

510(k) cleared

Orion

Resmed Corp · Jun 4, 2026 · K253553

FDA cleared the Orion from Resmed Corp on Jun 4, 2026 under K253553, a traditional 510(k). The device falls under product code BZD, Ventilator, Non-Continuous (Respirator), regulated at 21 CFR 868.5905 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Nov 14, 2025. The decision came 202 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: K254104 (ResScan Essentials), K251889 (myAir), K251661 (Mariana Minerva; Mariana Nimbus), K251657 (Personalized Therapy Comfort Settings (PTCS)).

Questions & Answers

What did FDA clear under K253553?

K253553 is the FDA 510(k) for Orion, submitted by Resmed Corp. FDA's decision date was Jun 4, 2026, under product code BZD (Ventilator, Non-Continuous (Respirator)).

Who makes the Orion?

Resmed Corp, based in San Diego, CA, is the applicant of record for K253553.

How long did the K253553 review take?

FDA received the submission on Nov 14, 2025 and issued its decision on Jun 4, 2026, 202 days later.

← All decisions in June 2026

Sources