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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 / K261136

510(k) cleared

Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)

Guangzhou Daxin Health Technology Co., Ltd. · Jul 23, 2026 · K261136

FDA cleared the Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) from Guangzhou Daxin Health Technology Co., Ltd. on Jul 23, 2026 under K261136, a traditional 510(k). The device falls under product code DXN, System, Measurement, Blood-Pressure, Non-Invasive, regulated at 21 CFR 870.1130 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 7, 2026. The decision came 107 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Guangzhou Daxin Health Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261136?

K261136 is the FDA 510(k) for Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D), submitted by Guangzhou Daxin Health Technology Co., Ltd.. FDA's decision date was Jul 23, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)?

Guangzhou Daxin Health Technology Co., Ltd., based in Guangzhou, is the applicant of record for K261136.

How long did the K261136 review take?

FDA received the submission on Apr 7, 2026 and issued its decision on Jul 23, 2026, 107 days later.

← All decisions in July 2026