PRESSONE™

PRESSONE™ is a sterile, single-use disposable hypodermic needle (25G x 5/8") with a stainless steel cannula and polypropylene luer-lock hub designed to deliver or withdraw fluids from the body. It is indicated for use with syringes for general purpose fluid injection and withdrawal, sterilized by gamma radiation with a 5-year shelf life, and individually packaged in a hard plastic container.

The device is technologically identical to the BD Hypoint predicate device across all key characteristics: same gauge (25G) and length (5/8"), same stainless steel cannula and polypropylene hub components, same mechanism of action (mechanical penetration via beveled tip with single internal lumen), same sterilization method (gamma radiation), same shelf life (5 years), and same individual packaging (hard container with peel-off label).

Performance testing per ISO 80369-7:2016 (connectors for hypodermic applications), ISO 9626:2016 (stainless steel needle tubing), ISO 7864:2016 (sterile hypodermic needles), and USP <788> (particulate matter). Biocompatibility per ISO 10993-1:2018. Packaging and sterilization validation per ISO 11137-1:2025, ASTM D4169, ASTM F1980-16, ASTM F1929-15, and ASTM F88/F88M-21.

The PRESSONE™ is substantially equivalent to the BD Hypoint predicate because it is identical in design, materials, manufacturing, sterilization, and functional performance. Both devices use the same technology (mechanical penetration via beveled stainless steel needle with single lumen), have identical specifications, and meet the same performance and biocompatibility standards. Non-clinical testing confirms functional performance equivalent to the predicate, supporting substantial equivalence in both design and technological characteristics.