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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 / February 2026 / K253228

510(k) cleared

YUWELL® Electronic Blood Pressure Monitor (YE650AR)

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · Feb 23, 2026 · K253228

FDA cleared the YUWELL® Electronic Blood Pressure Monitor (YE650AR) from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. on Feb 23, 2026 under K253228, 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 Sep 29, 2025. The decision came 147 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K261571 (Manual Wheelchair (H008, PCK7)), K252779 (YUWELL® Electronic Blood Pressure Monitor (YE630CR)), K252805 (YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)).

Questions & Answers

What did FDA clear under K253228?

K253228 is the FDA 510(k) for YUWELL® Electronic Blood Pressure Monitor (YE650AR), submitted by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. FDA's decision date was Feb 23, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the YUWELL® Electronic Blood Pressure Monitor (YE650AR)?

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., based in Danyang, is the applicant of record for K253228.

How long did the K253228 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Feb 23, 2026, 147 days later.

← All decisions in February 2026

Sources