Abatement Technologies, Inc.

Abatement Technologies, Inc. specializes in air purification solutions, producing mobile and stationary high-efficiency filter air cleaners (often featuring HEPA filters) and ultraviolet ambient disinfection lights. These devices are designed to improve indoor air quality and reduce pathogens, such as airborne bacteria or viruses, in various environments.

Abatement Technologies, Inc. is based in the United States. As a US-based manufacturer, its devices fall under FDA jurisdiction, where they are classified as Class II medical devices. This classification requires pre-market authorisation via pathways like the FDA 510(k) process, ensuring compliance with safety and performance standards before commercialisation.

Abatement Technologies, Inc.’s devices are listed in the FDA 510(k) and FDA Unique Device Identification (UDI) registries. The 510(k) process confirms that new devices are substantially equivalent to legally marketed predecessors, while UDI registration ensures traceability and transparency in the supply chain. Both registries are critical for tracking authorised devices and maintaining compliance with US medical device regulations.

Abatement Technologies, Inc.’s devices are classified as Class II under FDA regulations. This classification indicates moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness. While not as stringent as Class III (high-risk) devices, Class II devices still undergo pre-market review—such as the 510(k) pathway—to validate their performance and compliance with applicable standards before they can be marketed.