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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 / December 2025 / K251657

510(k) cleared

Personalized Therapy Comfort Settings (PTCS)

Resmed Corp · Dec 5, 2025 · K251657

FDA cleared the Personalized Therapy Comfort Settings (PTCS) from Resmed Corp on Dec 5, 2025 under K251657, 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 May 30, 2025. The decision came 189 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), K251889 (myAir), K251661 (Mariana Minerva; Mariana Nimbus).

Questions & Answers

What did FDA clear under K251657?

K251657 is the FDA 510(k) for Personalized Therapy Comfort Settings (PTCS), submitted by Resmed Corp. FDA's decision date was Dec 5, 2025, under product code BZD (Ventilator, Non-Continuous (Respirator)).

Who makes the Personalized Therapy Comfort Settings (PTCS)?

Resmed Corp, based in San Diego, CA, is the applicant of record for K251657.

How long did the K251657 review take?

FDA received the submission on May 30, 2025 and issued its decision on Dec 5, 2025, 189 days later.

← All decisions in December 2025

Sources