Understanding SoClean3+ and FDA Authorization

SoClean products have received considerable attention in the CPAP community because they use ozone as part of a supplemental equipment-treatment process.

In August 2024, FDA authorized the SoClean3+ Bacterial Reduction Device through the De Novo pathway. Understanding exactly what that authorization covers is important because it does not mean the device replaces routine CPAP cleaning.

What FDA Authorized

FDA classified SoClean3+ as a Class II respiratory accessory microbial reduction device under 21 CFR §880.6993.

Its authorized use is as an adjunct after regular cleaning to reduce bacterial populations on certain compatible CPAP masks and ventilation hoses. FDA specifically states that SoClean3+ must not replace the cleaning procedures recommended by the manufacturers of the CPAP mask and hose.

The authorization was based on demonstrated in-vitro bacterial reduction under the conditions evaluated by FDA. FDA also states that a correlation between those laboratory results and clinical outcomes has not been established.

FDA Authorization Does Not Replace Routine Cleaning

One of the most important distinctions is that SoClean3+ is a supplemental bacterial-reduction device, not a substitute for physical washing.

FDA continues to recommend following the CPAP manufacturer's cleaning instructions. CPAP manufacturers commonly recommend cleaning detachable accessories such as masks and tubing with mild soap and water.

Physical washing and bacterial reduction are different processes.

Washing can physically remove material such as oils, residue, dust, and deposits from compatible surfaces. A supplemental microbial-reduction process does not eliminate the need to perform the manufacturer's recommended cleaning procedure first.

SoClean2 and SoClean3 Recall Information

In November 2023, SoClean announced a voluntary recall involving SoClean2 and SoClean3 equipment.

The corrective action included updated instructions and a hose-and-mask adapter intended to reduce potential ozone exposure and prevent ozone from entering the CPAP machine during use. FDA continues to advise affected users to follow the revised instructions.

The later SoClean3+ authorization should not be confused with the earlier SoClean2 and SoClean3 products involved in that recall.

Ozone and CPAP Equipment

FDA advises users to follow CPAP-manufacturer instructions regarding ozone and UV products.

For recalled Philips devices containing PE-PUR foam, FDA specifically advises against ozone and UV cleaners and states that ozone cleaners may worsen foam breakdown.

FDA's SoClean safety communication also notes that people with certain underlying lung or cardiovascular conditions may be particularly sensitive to ozone and should consult their healthcare provider before using SoClean equipment.

What SoClean3+ Is Designed to Do

SoClean3+ is designed to provide an additional bacterial-reduction step after compatible accessories have already been cleaned.

FDA's authorization identifies specific compatible equipment used during evaluation, including certain ResMed masks and tubing. FDA states that safe use with other respiratory devices and accessories has not been established.

This makes it important for users to check the current SoClean3+ instructions and compatibility information before use.

Washing and Supplemental Treatment Are Different

Routine physical cleaning and supplemental bacterial reduction should not be treated as interchangeable.

For routine CPAP maintenance:

Follow the cleaning instructions supplied by the CPAP manufacturer, use only compatible cleaning products and methods, rinse washable accessories thoroughly, and allow them to dry completely before reuse.

If a supplemental treatment device is used, it should be used only according to its authorized intended use and should not replace the manufacturer's regular cleaning instructions.

The Bottom Line

FDA has authorized SoClean3+ for a specific, limited use: as an adjunct after regular cleaning to reduce bacterial populations on certain compatible CPAP masks and ventilation hoses.

That authorization does not eliminate the need for normal CPAP cleaning.

Users should continue following the cleaning instructions supplied by their CPAP equipment manufacturer and should review the current FDA and manufacturer information when considering any supplemental treatment product.