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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 / April 2026 / K253982

510(k) cleared

Korotkoff sound blood pressure monitor

Beijing Hanvon Health Technology Co., Ltd. · Apr 21, 2026 · K253982

FDA cleared the Korotkoff sound blood pressure monitor from Beijing Hanvon Health Technology Co., Ltd. on Apr 21, 2026 under K253982, 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 Dec 12, 2025. The decision came 130 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Beijing Hanvon Health Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253982?

K253982 is the FDA 510(k) for Korotkoff sound blood pressure monitor, submitted by Beijing Hanvon Health Technology Co., Ltd.. FDA's decision date was Apr 21, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the Korotkoff sound blood pressure monitor?

Beijing Hanvon Health Technology Co., Ltd., based in Beijing, is the applicant of record for K253982.

How long did the K253982 review take?

FDA received the submission on Dec 12, 2025 and issued its decision on Apr 21, 2026, 130 days later.

← All decisions in April 2026