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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 / K252268

510(k) cleared

V series portable oxygen concentrator (V5, V5C, V6, V6C)

Shenzhen Harveymed Technology Co., Ltd. · Dec 16, 2025 · K252268

FDA cleared the V series portable oxygen concentrator (V5, V5C, V6, V6C) from Shenzhen Harveymed Technology Co., Ltd. on Dec 16, 2025 under K252268, 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 Jul 21, 2025. The decision came 148 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 Shenzhen Harveymed Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252268?

K252268 is the FDA 510(k) for V series portable oxygen concentrator (V5, V5C, V6, V6C), submitted by Shenzhen Harveymed Technology Co., Ltd.. FDA's decision date was Dec 16, 2025, under product code CAW (Generator, Oxygen, Portable).

Who makes the V series portable oxygen concentrator (V5, V5C, V6, V6C)?

Shenzhen Harveymed Technology Co., Ltd., based in Shenzhen, is the applicant of record for K252268.

How long did the K252268 review take?

FDA received the submission on Jul 21, 2025 and issued its decision on Dec 16, 2025, 148 days later.

← All decisions in December 2025