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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 / March 2026 / K253838

510(k) cleared

Lifemotion Disposable Membrane Oxygenator

Lifemotion Medical Technology Co., Ltd. · Mar 16, 2026 · K253838

FDA cleared the Lifemotion Disposable Membrane Oxygenator from Lifemotion Medical Technology Co., Ltd. on Mar 16, 2026 under K253838, a traditional 510(k). The device falls under product code DTZ, Oxygenator, Cardiopulmonary Bypass, regulated at 21 CFR 870.4350 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 1, 2025. The decision came 105 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 Lifemotion Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253838?

K253838 is the FDA 510(k) for Lifemotion Disposable Membrane Oxygenator, submitted by Lifemotion Medical Technology Co., Ltd.. FDA's decision date was Mar 16, 2026, under product code DTZ (Oxygenator, Cardiopulmonary Bypass).

Who makes the Lifemotion Disposable Membrane Oxygenator?

Lifemotion Medical Technology Co., Ltd., based in Shenzhen, is the applicant of record for K253838.

How long did the K253838 review take?

FDA received the submission on Dec 1, 2025 and issued its decision on Mar 16, 2026, 105 days later.

← All decisions in March 2026