Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)

The Welch Allyn FlexiPort Blood Pressure Cuffs are noninvasive blood pressure measurement devices used with manual or automated sphygmomanometers to determine systolic/diastolic blood pressure in pediatric through adult patients. The cuffs feature a 360-degree rotating FlexiPort connector that reduces tube kinking and allows the cuff to be quickly exchanged between devices while tubing remains attached. Available in Reusable, Soft, and Vinyl variants in multiple sizes compliant with AAMI/AHA sizing standards.

The proposed devices have the same fundamental design and operation as the predicate (1-piece cuff with integrated bladder, FlexiPort feature, 1 or 2-tube configurations). Material changes include Polyether polyurethane film coated nylon for Reusable cuffs and white spunlaced polyester nonwoven fabric for Soft and Vinyl cuffs, replacing prior polyurethane-coated nylon and PVC materials respectively. Packaging quantities were reduced from 50 to 20 units per shipping box for Soft and Vinyl products. Testing upgraded to ANSI AAMI ISO 81060-1:2013 standard (incorporating AHA guidelines) and expanded biocompatibility testing per ISO 10993 series.

ANSI AAMI ISO 81060-1:2013 (non-automated sphygmomanometer requirements), ISO 10993-1:2018, ISO 10993-5:2014, ISO 10993-10:2021, ISO 10993-23:2021 (biocompatibility), ISO 14971:2019 (risk management), ANSI AAMI ISO 80369-1:2018 and 80369-5:2016 (connector standards), IEC 62366-1:2015 (usability engineering), and ISTA 3A:2018 (packaging durability).

The proposed devices are substantially equivalent because they have identical intended use, indications for use, patient population (pediatric through adult), principle of operation, and functional characteristics compared to the predicate K070060 cleared in 2007. Minor material and packaging differences do not raise new safety or effectiveness questions; design control activities and comprehensive bench testing including mechanical strength, durability, accuracy, and biocompatibility confirm the devices are as safe and effective as the predicate and meet all current FDA-recognized standards.