Medical devices are regulated by the Food and Drug Administration (FDA), which is the U.S. federal agency that is responsible for ensuring that medical devices intended for human use are safe and effective. This includes continuous positive airway pressure (CPAP) cleaning and disinfecting devices.
We have seen two primary types of medical devices that claim to clean CPAPs. One type uses ozone gas, the second type uses ultraviolet (UV) light. To date, the FDA has not approved or cleared either type of machine to clean CPAPs.
In fact, the FDA expressly communicated to Amazon that the above types of cleaning devices are unapproved. Class I and Class II non-exempt medical devices must be cleared by the FDA for sale in the U.S. (for more information, see 510(k) Clearances). Only products that comply with FDA requirements and are authorized may be sold on Amazon.