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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 / August 2026 / K260171

510(k) cleared

Portable Oxygen Concentrator (PO1 5B, PO1 6B)

BMC Medical Co., Ltd. · Aug 14, 2026 · K260171

FDA cleared the Portable Oxygen Concentrator (PO1 5B, PO1 6B) from BMC Medical Co., Ltd. on Aug 14, 2026 under K260171, 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 Jan 21, 2026. The decision came 205 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

BMC Medical Co., Ltd. has one other decision in the tracker over the last 12 months: K253166 (F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)).

Questions & Answers

What did FDA clear under K260171?

K260171 is the FDA 510(k) for Portable Oxygen Concentrator (PO1 5B, PO1 6B), submitted by BMC Medical Co., Ltd.. FDA's decision date was Aug 14, 2026, under product code CAW (Generator, Oxygen, Portable).

Who makes the Portable Oxygen Concentrator (PO1 5B, PO1 6B)?

BMC Medical Co., Ltd., based in Beijing, is the applicant of record for K260171.

How long did the K260171 review take?

FDA received the submission on Jan 21, 2026 and issued its decision on Aug 14, 2026, 205 days later.

← All decisions in August 2026

Sources