Clearance Summary
YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff received FDA 510(k) clearance under submission number K260747, sponsored by Nihon Kohden Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-05-06.
- Submission: K260747
- Applicant / Sponsor: Nihon Kohden Corporation
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1120
- Decision date: 2026-05-06
Classification & Regulation
This clearance is catalogued under FDA product code DXQ and 21 CFR 870.1120, within the Cardiovascular review panel as a Class II device.