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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K260747
Device Name YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff
Applicant
Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuku-Ku
Tokyo,  JP 161-8560
Applicant Contact Charlemagne Chua
Correspondent
Nihon Kohden America, LLC
15353 Barranca Pkwy.
Irvine,  CA  92618
Correspondent Contact Charlemagne Chua
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received03/06/2026
Decision Date 05/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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