Nov 2019. Specifically for *sterilization*. Clearance under 510(k). "Chlorine Dioxide (ClO2) sterilization is a chemical-based sterilization method. The active sterilant is the gas phase of ClO2. The gas phase of ClO2 can readily penetrate device packaging and sterilize medical devices through an oxidative mechanism at low sterilant concentration at room temperature and at atmospheric pressure. This sterilization process is validated using the overkill method to achieve a sterility assurance level of 10-6. The residues formed during this sterilization process are chlorine dioxide, chlorates, and chlorite that have low toxicity concerns from the reported literature. Although material compatibility information is limited, ClO2 is not known to be incompatible with the most commonly used materials in medical devices such as stainless steel and some polymers."