CerroZone™ Receives FDA 510(k) Class II Clearance
Tuesday, August 16, 2022
CerroZone™ LLC has received 510(k) Class II clearance from the U.S. Food and Drug Administration (FDA) for its innovative mobile air purification device. This device is recognized as a recirculating air cleaner capable of eliminating airborne viruses and bacteria. The FDA's approval was contingent on rigorous testing conducted at accredited independent third-party facilities.
The CerroZone mobile unit is specifically designed to purify the air in various indoor spaces, including schools, retail environments, offices, and more. Independent testing conducted at MRI Global in Kansas City demonstrated that CerroZone's indoor system achieved an impressive 99.998 percent reduction of live COVID-19 Delta Variant in a single pass lasting approximately 1.2 seconds.
What sets the CerroZone product apart from other solutions is its utilization of patented ozone technology. Michael Duggan, President of CerroZone based in St. Louis, Missouri, stated, "This is the first technology to truly harness the disinfecting power of ozone in a way that is safe for consumers and the environment. It will fundamentally change the industry standard for air purification."
CerroZone had previously announced its attainment of Intertek's Zero Ozone Certification. The emissions of the CerroZone unit were measured at only .001 ppm, which is considered negligible according to UL 2998, the North American industry standard for ozone testing. This certification demonstrates the company's commitment to ensuring minimal ozone emissions.
One of the notable advantages of the CerroZone™ platform is its low maintenance requirements. Unlike filtration-based systems that necessitate quarterly replacement of filters and other components, the CerroZone unit only requires annual preventive maintenance.
Marlon Robinson, Director of Operations for CerroZone, expressed confidence in the system's exceptional quality, stating, "Today's news further validates the exceptional quality of our system. We knew the effectiveness of the CerroZone unit based on our prior testing, including on live COVID-19. To show similar effectiveness on a different strain reinforces that CerroZone is positioned to aid the public in the fight against emerging and future variants."
Robinson also emphasized the company's readiness to commercialize this groundbreaking technology. CerroZone has conducted successful field trials, consistently demonstrating the product's exceptional performance. The company looks forward to providing the market with an effective, proven solution that includes an attractive preventive maintenance schedule.
The patented CerroZone system was developed in collaboration with Micron Pure™, a company within the Hecto Group™. This collaboration highlights the commitment to innovation and advancing air purification technology to meet the evolving needs of various industries.