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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 / March 2026 / K252779

510(k) cleared

YUWELL® Electronic Blood Pressure Monitor (YE630CR)

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · Mar 5, 2026 · K252779

FDA cleared the YUWELL® Electronic Blood Pressure Monitor (YE630CR) from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. on Mar 5, 2026 under K252779, 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 2, 2025. The decision came 184 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)), K253228 (YUWELL® Electronic Blood Pressure Monitor (YE650AR)), K252805 (YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)).

Questions & Answers

What did FDA clear under K252779?

K252779 is the FDA 510(k) for YUWELL® Electronic Blood Pressure Monitor (YE630CR), submitted by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. FDA's decision date was Mar 5, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the YUWELL® Electronic Blood Pressure Monitor (YE630CR)?

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., based in Zhenjiang, is the applicant of record for K252779.

How long did the K252779 review take?

FDA received the submission on Sep 2, 2025 and issued its decision on Mar 5, 2026, 184 days later.

← All decisions in March 2026

Sources