PETERBOROUGH, New Hampshire—SoClean, a bacterial reduction system for continuous positive airway pressure (CPAP) hoses and masks, announced its “SoClean 3+” equipment has been granted de novo clearance by the Food and Drug Administration (FDA). The SoClean 3+, an at-home cleaning device for CPAP hoses and masks, is the only FDA-cleared product intended to reduce bacterial populations on compatible masks and ventilation hoses. The de novo classification pathway was introduced as a part of the FDA Modernization Act of 1977 as an alternative way of classifying low- to moderate-risk devices.
The SoClean 3+ is an over-the-counter device that has achieved 99.9% bacterial reduction in CPAP hoses and masks. SoClean aims to provide CPAP users and the clinical field with the development of products that are user-friendly and significantly reduce bacterial populations in CPAP hoses and masks. SoClean has more than 150 patents issued worldwide, which focus on SoClean's bacterial reduction systems, methods, devices and designs.
"Sleep apnea is a growing issue worldwide, which impacts user's ability to get a proper night's rest,” said Rober Wilkins, CEO of SoClean. “Ensuring bacteria in CPAP hoses and masks can be easily reduced following cleaning is essential for daily use and maintenance by users.”
SoClean is working toward establishing additional hoses and masks for use with the SoClean 3+ bacterial reduction device. The SoClean 3+ is currently established for use with multiple ResMed brand nasal masks and tubing systems.
Additional information on the SoClean 3+ and current SoClean product upgrades can be found at soclean.com.
