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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 / April 2026 / K253166

510(k) cleared

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)

BMC Medical Co., Ltd. · Apr 29, 2026 · K253166

FDA cleared the F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) from BMC Medical Co., Ltd. on Apr 29, 2026 under K253166, a traditional 510(k). The device falls under product code BZD, Ventilator, Non-Continuous (Respirator), regulated at 21 CFR 868.5905 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Sep 26, 2025. The decision came 215 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: K260171 (Portable Oxygen Concentrator (PO1 5B, PO1 6B)).

Questions & Answers

What did FDA clear under K253166?

K253166 is the FDA 510(k) for F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S), submitted by BMC Medical Co., Ltd.. FDA's decision date was Apr 29, 2026, under product code BZD (Ventilator, Non-Continuous (Respirator)).

Who makes the F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)?

BMC Medical Co., Ltd., based in Beijing, is the applicant of record for K253166.

How long did the K253166 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Apr 29, 2026, 215 days later.

← All decisions in April 2026

Sources