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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 / June 2026 / K252399

510(k) cleared

Portable Oxygen Concentrator

Honsun (Nantong) Co., Ltd. · Jun 17, 2026 · K252399

FDA cleared the Portable Oxygen Concentrator from Honsun (Nantong) Co., Ltd. on Jun 17, 2026 under K252399, 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 31, 2025. The decision came 321 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Honsun (Nantong) Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K260260 (Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)), K251795 (Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)).

Questions & Answers

What did FDA clear under K252399?

K252399 is the FDA 510(k) for Portable Oxygen Concentrator, submitted by Honsun (Nantong) Co., Ltd.. FDA's decision date was Jun 17, 2026, under product code CAW (Generator, Oxygen, Portable).

Who makes the Portable Oxygen Concentrator?

Honsun (Nantong) Co., Ltd., based in Nantong, is the applicant of record for K252399.

How long did the K252399 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on Jun 17, 2026, 321 days later.

← All decisions in June 2026

Sources