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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 / K261494

510(k) cleared

Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)

Shanghai Hulu Devices Co., Ltd. · Jul 31, 2026 · K261494

FDA cleared the Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) from Shanghai Hulu Devices Co., Ltd. on Jul 31, 2026 under K261494, a traditional 510(k). The device falls under product code DQD, Stethoscope, Electronic, regulated at 21 CFR 870.1875 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 6, 2026. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Shanghai Hulu Devices Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261494?

K261494 is the FDA 510(k) for Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730), submitted by Shanghai Hulu Devices Co., Ltd.. FDA's decision date was Jul 31, 2026, under product code DQD (Stethoscope, Electronic).

Who makes the Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)?

Shanghai Hulu Devices Co., Ltd., based in Shanghai, is the applicant of record for K261494.

How long did the K261494 review take?

FDA received the submission on May 6, 2026 and issued its decision on Jul 31, 2026, 86 days later.

← All decisions in July 2026