SoClean 3+ is a Revolutionary Solution for Your CPAP^** Accessory Care

The SoClean 3+ is 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 any other respiratory devices or accessories has not been established. For the latest information about SoClean 3+, sign up for updates using the above form.

Hand-washing your CPAP equipment is meant to remove organic material whereas the SoClean 3+ is intended to be used as an adjunct to hand-washing and has been demonstrated to achieve 99.9% bacterial reduction* in CPAP hoses and masks providing you with fresh equipment after each use.

The FDA De Novo clearance is an FDA marketing authorization pathway in which a new type of low to moderate risk medical device classification is established. Obtaining De Novo clearance for the SoClean 3+ means that SoClean worked with the FDA to create a new Class II category named, "Respiratory accessory microbial reduction devices". As the only product in this category, SoClean 3+ is the sole FDA-cleared product that provides users with adjunct bacterial reduction of CPAP hoses and masks.
For more information on the De Novo process, see the FDA's website.

Since the SoClean just received De Novo clearance, units of the SoClean 3+ are not expected until March of 2025. For the most up-to-date information on the SoClean 3+ product release, sign up for updates using the above form.

No. The SoClean3+ was cleared as an adjunct to your CPAP manufacturer's cleaning instructions.

No, the SoClean 3+ is an over-the-counter device. Once publicly available, it can be purchased online at www.SoClean.com.