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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 / October 2025 / K251795

510(k) cleared

Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)

Honsun (Nantong) Co., Ltd. · Oct 9, 2025 · K251795

FDA cleared the Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) from Honsun (Nantong) Co., Ltd. on Oct 9, 2025 under K251795, a special 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 Jun 12, 2025. The decision came 119 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Honsun (Nantong) Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K252399 (Portable Oxygen Concentrator), K260260 (Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)).

Questions & Answers

What did FDA clear under K251795?

K251795 is the FDA 510(k) for Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753), submitted by Honsun (Nantong) Co., Ltd.. FDA's decision date was Oct 9, 2025, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)?

Honsun (Nantong) Co., Ltd., based in Nanton, is the applicant of record for K251795.

How long did the K251795 review take?

FDA received the submission on Jun 12, 2025 and issued its decision on Oct 9, 2025, 119 days later.

← All decisions in October 2025

Sources