Disposable Neonatal NIBP Cuff (U1681S-C51N)

The Disposable Neonatal NIBP Cuff (Model U1681S-C51N) is a single-patient-use, non-sterile accessory for noninvasive blood pressure measurement in neonates. It is designed for limb circumferences of 3–6 cm and is used with compatible blood pressure monitors employing oscillometry, then disposed of after use to reduce cross-contamination risks.

The subject device is identical to the predicate device in materials (TPU film cuff, PVC tubing, molded nylon hook, nylon loop), tube configuration (single-tube), pressure limits (0–300 mmHg), and non-sterile status. The key difference is that the U1681S-C51N adds a smaller neonatal size covering the 3–6 cm limb circumference range, whereas the predicate device's smallest size (U1682S-C51N) covers 4–8 cm.

ISO 81060-1:2007 (non-invasive sphygmomanometers — requirements and test methods for non-automated measurement); ISO 80601-2-30:2018 (automated non-invasive sphygmomanometers); ISO 10993-5 (cytotoxicity); ISO 10993-10 (skin sensitization); ISO 10993-23 (skin irritation).

The subject device is substantially equivalent to the predicate because it has identical intended use, materials, construction, performance characteristics, and regulatory classification. Performance testing confirmed it meets applicable requirements under ISO standards. The only difference is the addition of a smaller cuff size (3–6 cm), which does not affect safety or effectiveness. Biocompatibility testing demonstrates the materials are suitable for short-term skin contact.