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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 / K251534

510(k) cleared

Oxygen Concentrator (J10A)

Foshan Kycare Medical Equipment Co., Ltd. · Dec 29, 2025 · K251534

FDA cleared the Oxygen Concentrator (J10A) from Foshan Kycare Medical Equipment Co., Ltd. on Dec 29, 2025 under K251534, 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 May 19, 2025. The decision came 224 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Foshan Kycare Medical Equipment Co., Ltd. has one other decision in the tracker over the last 12 months: K251607 (Oxygen Concentrator (J5A)).

Questions & Answers

What did FDA clear under K251534?

K251534 is the FDA 510(k) for Oxygen Concentrator (J10A), submitted by Foshan Kycare Medical Equipment Co., Ltd.. FDA's decision date was Dec 29, 2025, under product code CAW (Generator, Oxygen, Portable).

Who makes the Oxygen Concentrator (J10A)?

Foshan Kycare Medical Equipment Co., Ltd., based in Foshan, is the applicant of record for K251534.

How long did the K251534 review take?

FDA received the submission on May 19, 2025 and issued its decision on Dec 29, 2025, 224 days later.

← All decisions in December 2025

Sources