WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K252616

510(k) cleared

Portable oxygen concentrator (JLO-190P)

Shenzhen Homed Medical Device Co., Ltd. · Dec 22, 2025 · K252616

FDA cleared the Portable oxygen concentrator (JLO-190P) from Shenzhen Homed Medical Device Co., Ltd. on Dec 22, 2025 under K252616, 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 Aug 19, 2025. The decision came 125 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 Homed Medical Device Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252616?

K252616 is the FDA 510(k) for Portable oxygen concentrator (JLO-190P), submitted by Shenzhen Homed Medical Device Co., Ltd.. FDA's decision date was Dec 22, 2025, under product code CAW (Generator, Oxygen, Portable).

Who makes the Portable oxygen concentrator (JLO-190P)?

Shenzhen Homed Medical Device Co., Ltd., based in Shenzhen, is the applicant of record for K252616.

How long did the K252616 review take?

FDA received the submission on Aug 19, 2025 and issued its decision on Dec 22, 2025, 125 days later.

← All decisions in December 2025