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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 / May 2026 / K252965

510(k) cleared

Oxygen Concentrator (OX-5A, OX-5C)

Oxytek Medical Technology Co., Ltd. · May 29, 2026 · K252965

FDA cleared the Oxygen Concentrator (OX-5A, OX-5C) from Oxytek Medical Technology Co., Ltd. on May 29, 2026 under K252965, 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 Sep 17, 2025. The decision came 254 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 Oxytek Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252965?

K252965 is the FDA 510(k) for Oxygen Concentrator (OX-5A, OX-5C), submitted by Oxytek Medical Technology Co., Ltd.. FDA's decision date was May 29, 2026, under product code CAW (Generator, Oxygen, Portable).

Who makes the Oxygen Concentrator (OX-5A, OX-5C)?

Oxytek Medical Technology Co., Ltd., based in Chencun Town, Shunde District, Foshan, is the applicant of record for K252965.

How long did the K252965 review take?

FDA received the submission on Sep 17, 2025 and issued its decision on May 29, 2026, 254 days later.

← All decisions in May 2026