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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 / K253133

510(k) cleared

Wrist Blood Pressure Monitor (BPM-W1VL)

Shenzhen Imdk Medical Technology Co., Ltd. · Feb 13, 2026 · K253133

FDA cleared the Wrist Blood Pressure Monitor (BPM-W1VL) from Shenzhen Imdk Medical Technology Co., Ltd. on Feb 13, 2026 under K253133, 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 141 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shenzhen Imdk Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K252655 (Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)).

Questions & Answers

What did FDA clear under K253133?

K253133 is the FDA 510(k) for Wrist Blood Pressure Monitor (BPM-W1VL), submitted by Shenzhen Imdk Medical Technology Co., Ltd.. FDA's decision date was Feb 13, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the Wrist Blood Pressure Monitor (BPM-W1VL)?

Shenzhen Imdk Medical Technology Co., Ltd., based in Shenzhen, is the applicant of record for K253133.

How long did the K253133 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Feb 13, 2026, 141 days later.

← All decisions in February 2026

Sources