HAI’s UV microbial reduction

HAI Solutions Receives FDA De Novo Grant for QIKCAP System

January 2, 2026
8:56 am

HAI Solutions, a leading innovator in ultraviolet (UVC) microbial reduction medical devices, announced that the U.S. Food and Drug Administration (FDA) has granted De Novo classification for its QIKCAP System. This marks the first and only FDA-Granted Ultraviolet light-based microbial reduction device for luer-activated valves, establishing a new Class II medical device category.

The QIKCAP System, comprising the QIKCAP Device and single-use QIKCAP Cap, is engineered to supplement manual disinfection protocols for needle-free luer connectors in intravascular applications. The QIKCAP Device delivers powerful, targeted UVC irradiation to the connector septum, resulting in rapid, 10-second microbial reduction. The QIKCAP Cap further provides a protective physical barrier, shielding the connector from environmental contamination for up to 7 days, if not in use.

This positions HAI Solutions as a leader in UVC microbial reduction medical devices, bolstered by a growing portfolio that includes a strategic partnership with Intellego Technologies for an innovative chromatic dosimeter formulated specifically for UVC applications. HAI Solutions strongly supports FDA regulation of UVC healthcare devices, emphasising the importance of rigorous standards to ensure safety and efficacy in patient care.

HAI Solutions Receives FDA De Novo Grant for QIKCAP System

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