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

The YP-710T Series NIBP Cuff is a reusable, non-sterile blood pressure cuff for repeated use with multiple patients in pediatric and adult sizes. The YP-840T Series Disposable Cuff is a single-use, non-sterile version of the same device. Both cuffs connect to Nihon Kohden automated blood pressure measurement systems to measure non-invasive blood pressure and are intended for use by qualified medical personnel in medical facilities.

The subject devices feature either a legacy locking connector (twist type) or a small-bore connector compliant with IEC 80369-5, whereas the predicate used multiple connector types including screw, sub-miniature, and bayonet connectors. The YP-710T and YP-840T cuffs are available in six size models for pediatric and adult populations only, while the predicate included neonatal sizes. Materials differ slightly: YP-710T uses polyester and PVC; YP-840T uses laminate polyester/PVC. Operating and storage temperature ranges differ from the predicate.

ISO 14971:2019 (risk management), ISO 10993 series (biocompatibility including cytotoxicity, irritation, sensitization), IEC 80601-2-30:2018 (automated sphygmomanometers), ISO 81060-1:2007 (non-invasive sphygmomanometer requirements), IEC 80369-5:2016 (small-bore connectors for limb cuff inflation), and ASTM F1980-21 (accelerated aging of sterile barrier systems).

The YP-710T and YP-840T series are substantially equivalent to the SOFT-CUF predicate device (K120125) because they share the same intended use (non-invasive blood pressure measurement), same indications for use (accessories for NIBP measurement systems), same product code (DXQ), same regulation (21 CFR 870.1120), and same device classification (Class II). Design differences—such as connector type and narrower patient size range—are based on compliance with current applicable standards and do not impact safety or effectiveness. Performance testing using the same methods and specifications as the predicate demonstrates equivalency.