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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 / K260260

510(k) cleared

Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)

Honsun (Nantong) Co., Ltd. · Apr 28, 2026 · K260260

FDA cleared the Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) from Honsun (Nantong) Co., Ltd. on Apr 28, 2026 under K260260, 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 Jan 28, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Honsun (Nantong) Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K252399 (Portable Oxygen Concentrator), K251795 (Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)).

Questions & Answers

What did FDA clear under K260260?

K260260 is the FDA 510(k) for Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569), submitted by Honsun (Nantong) Co., Ltd.. FDA's decision date was Apr 28, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)?

Honsun (Nantong) Co., Ltd., based in Nantong, is the applicant of record for K260260.

How long did the K260260 review take?

FDA received the submission on Jan 28, 2026 and issued its decision on Apr 28, 2026, 90 days later.

← All decisions in April 2026

Sources