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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 / May 2026 / K254104

510(k) cleared

ResScan Essentials

Resmed Corp · May 27, 2026 · K254104

FDA cleared the ResScan Essentials from Resmed Corp on May 27, 2026 under K254104, 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 Dec 19, 2025. The decision came 159 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), K251889 (myAir), K251661 (Mariana Minerva; Mariana Nimbus), K251657 (Personalized Therapy Comfort Settings (PTCS)).

Questions & Answers

What did FDA clear under K254104?

K254104 is the FDA 510(k) for ResScan Essentials, submitted by Resmed Corp. FDA's decision date was May 27, 2026, under product code BZD (Ventilator, Non-Continuous (Respirator)).

Who makes the ResScan Essentials?

Resmed Corp, based in San Diego, CA, is the applicant of record for K254104.

How long did the K254104 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on May 27, 2026, 159 days later.

← All decisions in May 2026

Sources