FDA OKs SoClean’s Latest CPAP Mask & Hose Bacterial Reduction Device

SoClean, a company pioneering bacterial reduction systems for CPAP hoses and masks, has been awarded U.S. Food and Drug Administration (FDA) de novo clearance for its SoClean 3+ device.
 
According to the company, SoClean 3+ is the only FDA-cleared product used as an adjunct to reduce bacterial populations on some compatible, home-use CPAP mask and ventilation hoses after cleaning. It’s been shown to achieve 99.9% bacterial reduction in CPAP hoses and masks.
 
SoClean 3+ is an over-the-counter device and can be purchased online. It’s currently established for use with the ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing), and SlimLine (tubing) for the ResMed AirSense 10 CPAP.
 
The company said it’s working to establish further hoses and masks for use with SoClean 3+. The company will instruct customers on how to upgrade current devices to SoClean 3+ in the next 60 days. SoClean will also offer an upgrade program to uses of any other CPAP hose and mask cleaning devices.
 
The company has more than 150 patents worldwide focused on its 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 SoClean CEO Robert Wilkins. “Ensuring bacteria in CPAP hoses and masks can be easily reduced following cleaning is essential for daily use and maintenance by users.”