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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 / September 2025 / K243833

510(k) cleared

Portable oxygen concentrator (JAY-1000P)

Longfian Scitech Co., Ltd. · Sep 29, 2025 · K243833

FDA cleared the Portable oxygen concentrator (JAY-1000P) from Longfian Scitech Co., Ltd. on Sep 29, 2025 under K243833, 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 Dec 13, 2024. The decision came 290 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 Longfian Scitech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243833?

K243833 is the FDA 510(k) for Portable oxygen concentrator (JAY-1000P), submitted by Longfian Scitech Co., Ltd.. FDA's decision date was Sep 29, 2025, under product code CAW (Generator, Oxygen, Portable).

Who makes the Portable oxygen concentrator (JAY-1000P)?

Longfian Scitech Co., Ltd., based in Baoding, is the applicant of record for K243833.

How long did the K243833 review take?

FDA received the submission on Dec 13, 2024 and issued its decision on Sep 29, 2025, 290 days later.

← All decisions in September 2025