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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 / June 2026 / K253124

510(k) cleared

Upper arm electronic blood pressure monitor (XB-01)

Shenzhen Ziqing Medical Equipment Co., Ltd. · Jun 3, 2026 · K253124

FDA cleared the Upper arm electronic blood pressure monitor (XB-01) from Shenzhen Ziqing Medical Equipment Co., Ltd. on Jun 3, 2026 under K253124, 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 25, 2025. The decision came 251 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shenzhen Ziqing Medical Equipment Co., Ltd. has one other decision in the tracker over the last 12 months: K253126 (Wrist Blood Pressure Monitor (XW-05)).

Questions & Answers

What did FDA clear under K253124?

K253124 is the FDA 510(k) for Upper arm electronic blood pressure monitor (XB-01), submitted by Shenzhen Ziqing Medical Equipment Co., Ltd.. FDA's decision date was Jun 3, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the Upper arm electronic blood pressure monitor (XB-01)?

Shenzhen Ziqing Medical Equipment Co., Ltd., based in Shenzhen, is the applicant of record for K253124.

How long did the K253124 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Jun 3, 2026, 251 days later.

← All decisions in June 2026

Sources