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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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 one other decision in the tracker over the last 12 months: K251641 (GF-310R Multigas Unit (GF-310R)).

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