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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 / July 2026 / K261011

510(k) cleared

Sleep Apnea Feature (v2.0)

Samsung Electronics Co., Ltd. · Jul 20, 2026 · K261011

FDA cleared the Sleep Apnea Feature (v2.0) from Samsung Electronics Co., Ltd. on Jul 20, 2026 under K261011, a traditional 510(k). The device falls under product code QZW, Over-The-Counter Device To Assess Risk Of Sleep Apnea, regulated at 21 CFR 868.2378 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Mar 26, 2026. The decision came 116 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Samsung Electronics Co., Ltd. has one other decision in the tracker over the last 12 months: K261187 (Hearing Aid Feature).

Questions & Answers

What did FDA clear under K261011?

K261011 is the FDA 510(k) for Sleep Apnea Feature (v2.0), submitted by Samsung Electronics Co., Ltd.. FDA's decision date was Jul 20, 2026, under product code QZW (Over-The-Counter Device To Assess Risk Of Sleep Apnea).

Who makes the Sleep Apnea Feature (v2.0)?

Samsung Electronics Co., Ltd., based in Suwon-Si, is the applicant of record for K261011.

How long did the K261011 review take?

FDA received the submission on Mar 26, 2026 and issued its decision on Jul 20, 2026, 116 days later.

← All decisions in July 2026

Sources