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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 / July 2026 / K253044

510(k) cleared

RXiBreeze PAP System (RXiBreeze 20C)

Resvent Medical Technology Co., Ltd. · Jul 23, 2026 · K253044

FDA cleared the RXiBreeze PAP System (RXiBreeze 20C) from Resvent Medical Technology Co., Ltd. on Jul 23, 2026 under K253044, 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 Sep 22, 2025. The decision came 304 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Resvent Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253044?

K253044 is the FDA 510(k) for RXiBreeze PAP System (RXiBreeze 20C), submitted by Resvent Medical Technology Co., Ltd.. FDA's decision date was Jul 23, 2026, under product code BZD (Ventilator, Non-Continuous (Respirator)).

Who makes the RXiBreeze PAP System (RXiBreeze 20C)?

Resvent Medical Technology Co., Ltd., based in Shenzhen, is the applicant of record for K253044.

How long did the K253044 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Jul 23, 2026, 304 days later.

← All decisions in July 2026