NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)

The NIBP Cuff is a reusable, non-sterile accessory used with noninvasive blood pressure measurement systems in neonatal, infant, child, and adult sizes. It consists of a cuff with bladder and air hose (single or double tube) and is intended solely for blood pressure measurement as an accessory to compatible monitoring systems.

The device comes in 28 sizes with two material variants: BCS/BCD-X12 series use PU synthetic leather cuff with TPU bladder and PVC tubing; BCS/BCD-X22 series use Nylon cuff with TPU bladder and PVC tubing. Both variants meet 0–300 mmHg pressure range, <4 mmHg/min leakage, and conform to AHA bladder size recommendations. The subject device differs from the predicate primarily in material composition for some models and size range coverage.

ISO 81060-1 (non-invasive sphygmomanometers requirements and test methods), ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2021 (skin sensitization), and ISO 10993-23:2021 (irritation). Biocompatibility testing confirmed no cytotoxicity, sensitization, or irritation for skin-contacting materials.

The subject device has the same intended use, indications, and fundamental design as the predicate device (Caremed Reusable Blood Pressure Cuff, K182433). Material differences and size variations do not raise new safety or effectiveness questions because equivalent materials are biocompatible and size ranges align with or are covered by predicate specifications. Bench testing confirms the device meets all applicable performance standards, establishing substantial equivalence to the predicate.