FDA Grants 510(k) Clearance to Samsung Air Purifier
Samsung Electronics’ Bespoke Cube Air purifier has been awarded the FDA’s 510(k) clearance as a Class 2 (special controls) device.
After running for three hours, the cube filters out 99 percent of bacterial pathogens, such as bacteriophages, yellow staphylococcus and coliforms, the company said.
The device, which uses photocatalytic ultraviolet sterilization to rid the air of bacteria and viruses, was introduced on the Korean market in December 2020.
The FDA designates certain moderate-to-high-risk devices as Class 2 (special controls) and requires specific guidance for users to provide “reasonable assurance of their safety and effectiveness.”