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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 / K251764

510(k) cleared

Oxygen Concentrator-P2-O5E

Qingdao Kingon Medical Science and Technology Co., Ltd. · Dec 22, 2025 · K251764

FDA cleared the Oxygen Concentrator-P2-O5E from Qingdao Kingon Medical Science and Technology Co., Ltd. on Dec 22, 2025 under K251764, a traditional 510(k). The device falls under product code CAW, Generator, Oxygen, Portable, regulated at 21 CFR 868.5440 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jun 9, 2025. The decision came 196 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 Qingdao Kingon Medical Science and Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251764?

K251764 is the FDA 510(k) for Oxygen Concentrator-P2-O5E, submitted by Qingdao Kingon Medical Science and Technology Co., Ltd.. FDA's decision date was Dec 22, 2025, under product code CAW (Generator, Oxygen, Portable).

Who makes the Oxygen Concentrator-P2-O5E?

Qingdao Kingon Medical Science and Technology Co., Ltd., based in Qingdao, is the applicant of record for K251764.

How long did the K251764 review take?

FDA received the submission on Jun 9, 2025 and issued its decision on Dec 22, 2025, 196 days later.

← All decisions in December 2025