On Aug. 19, 2024, SoClean announced it received FDA De Novo clearance for the SoClean 3+, a bacterial reduction device for certain compatible CPAP masks and hoses.
About SoClean 3+
The SoClean 3+ is a single-patient home-use cleaning device for compatible CPAP masks and hoses designed to be used after recommended cleaning procedures. The device is intended to help continually reduce bacteria buildup. It sanitizes masks and tubing using activated oxygen, without the use of chemicals. SoClean 3+ is considered an adjunct solution for bacterial reduction; it is not intended to replace cleaning procedures recommended by CPAP mask and hose manufacturers.
According to the company’s press release, 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. The safe use of SoClean 3+ with other respiratory devices or accessories has not been established.
FDA De Novo classification is a marketing authorization pathway in which a new type of low to moderate risk medical device classification is established.
SoClean 3+ is an over-the-counter device. It is not yet available for public purchase.
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