FDA clearance for i3 ONE and i3 TWO

We did it! At the beginning of June, the Food and Drug Administration (FDA) granted 510(k) clearance for our i3 ONE, i3 TWO connect and i3 TWO direct water filters. This means that these products are now cleared as Class II medical devices in the USA. And now just one more step to launch: Our preparations are already in full swing, so that we can offer our water filters on the market in the United States in the very near future.

It has been a long road to reach this milestone, as FDA requirements are rightly regarded as particularly stringent. We are proud of the performance of our entire team during the clearance process and we look forward to the exciting phase of our forthcoming internationalization.

We at i3 Membrane (founded in Germany in 2013) have many years of experience in the field of life science filtration. Our compact and powerful water filters are easy to install at the outlets of faucets and showers. There they form a barrier against all waterborne germs in drinking water.

These products thus make an important contribution to interrupting contamination pathways in hospitals and other medical facilities. Thus immunocompromised and immunosuppressed patients in particular can be protected against infections caused by facultative pathogens.