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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 / K251581

510(k) cleared

Wearable Ambulatory Blood Pressure Monitor (WBP-02A)

Shenzhen Hingmed Medical Instrument Co., Ltd. · Feb 13, 2026 · K251581

FDA cleared the Wearable Ambulatory Blood Pressure Monitor (WBP-02A) from Shenzhen Hingmed Medical Instrument Co., Ltd. on Feb 13, 2026 under K251581, 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 May 23, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shenzhen Hingmed Medical Instrument Co., Ltd. has one other decision in the tracker over the last 12 months: K251307 (Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)).

Questions & Answers

What did FDA clear under K251581?

K251581 is the FDA 510(k) for Wearable Ambulatory Blood Pressure Monitor (WBP-02A), submitted by Shenzhen Hingmed Medical Instrument Co., Ltd.. FDA's decision date was Feb 13, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the Wearable Ambulatory Blood Pressure Monitor (WBP-02A)?

Shenzhen Hingmed Medical Instrument Co., Ltd., based in Shenzhen, is the applicant of record for K251581.

How long did the K251581 review take?

FDA received the submission on May 23, 2025 and issued its decision on Feb 13, 2026, 266 days later.

← All decisions in February 2026

Sources