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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 / January 2026 / K251307

510(k) cleared

Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)

Shenzhen Hingmed Medical Instrument Co., Ltd. · Jan 12, 2026 · K251307

FDA cleared the Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) from Shenzhen Hingmed Medical Instrument Co., Ltd. on Jan 12, 2026 under K251307, 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 Apr 28, 2025. The decision came 259 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: K251581 (Wearable Ambulatory Blood Pressure Monitor (WBP-02A)).

Questions & Answers

What did FDA clear under K251307?

K251307 is the FDA 510(k) for Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i), submitted by Shenzhen Hingmed Medical Instrument Co., Ltd.. FDA's decision date was Jan 12, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)?

Shenzhen Hingmed Medical Instrument Co., Ltd., based in Shenzhen, is the applicant of record for K251307.

How long did the K251307 review take?

FDA received the submission on Apr 28, 2025 and issued its decision on Jan 12, 2026, 259 days later.

← All decisions in January 2026

Sources