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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 / May 2026 / K253570

510(k) cleared

Blood Pressure Monitor (W06LT)

Shenzhen Jamr Technology Co., Ltd. · May 20, 2026 · K253570

FDA cleared the Blood Pressure Monitor (W06LT) from Shenzhen Jamr Technology Co., Ltd. on May 20, 2026 under K253570, 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 Nov 17, 2025. The decision came 184 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shenzhen Jamr Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K251331 (Blood Pressure Monitor (B73, BE23T)).

Questions & Answers

What did FDA clear under K253570?

K253570 is the FDA 510(k) for Blood Pressure Monitor (W06LT), submitted by Shenzhen Jamr Technology Co., Ltd.. FDA's decision date was May 20, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the Blood Pressure Monitor (W06LT)?

Shenzhen Jamr Technology Co., Ltd., based in Shenzhen, is the applicant of record for K253570.

How long did the K253570 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on May 20, 2026, 184 days later.

← All decisions in May 2026

Sources