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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 / May 2026 / K260747

510(k) cleared

YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff

Nihon Kohden Corporation · May 6, 2026 · K260747

FDA cleared the YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff from Nihon Kohden Corporation on May 6, 2026 under K260747, a traditional 510(k). The device falls under product code DXQ, Blood Pressure Cuff, regulated at 21 CFR 870.1120 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 6, 2026. The decision came 61 days later, inside the 90 FDA-day goal for a 510(k).

Nihon Kohden Corporation has 2 other decisions in the tracker over the last 12 months: K251641 (GF-310R Multigas Unit (GF-310R)), K251366 (EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)).

Questions & Answers

What did FDA clear under K260747?

K260747 is the FDA 510(k) for YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff, submitted by Nihon Kohden Corporation. FDA's decision date was May 6, 2026, under product code DXQ (Blood Pressure Cuff).

Who makes the YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff?

Nihon Kohden Corporation, based in Tokyo, is the applicant of record for K260747.

How long did the K260747 review take?

FDA received the submission on Mar 6, 2026 and issued its decision on May 6, 2026, 61 days later.

← All decisions in May 2026

Sources