HAI Solutions Receives FDA De Novo Grant for QIKCAP System: Pioneering UVC Technology for Microbial Reduction on Needleless IV Connectors

CARLSBAD, Calif., Dec. 30, 2025 /PRNewswire/ -- HAI Solutions, a leading innovator in ultraviolet (UVC) microbial reduction medical devices, today 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, emphasizing the importance of rigorous standards to ensure safety and efficacy in patient care.

"This De Novo Grant is a HUGE accomplishment for the HAI Solutions team," said Nick Perrenoud, CEO of HAI Solutions. "We are proud to bring this innovative technology to market, addressing a critical need in IV connector maintenance and protection."

HAI Solutions worked closely with the FDA throughout the De Novo process, adhering to general and special controls that required extensive performance testing under worst-case conditions. These measures ensure the device's reliability and safety in clinical settings. Under the conditions of testing, the combined use of an 3.15% CHG/70% IPA wipes applied for 5 seconds and the QIKCAP Device resulted in 4-log reductions in Staphylococcus aureus, Klebsiella pneumoniae, Staphylococcus epidermidis, and Enterobacter cloacae. The device has not shown a significant reduction in fungal organisms. A correlation to clinical infection-related outcomes has not been established.

About HAI Solutions
Based in Carlsbad, California, HAI Solutions is pioneering a comprehensive portfolio of cutting-edge intravenous therapy solutions designed to combat IV contamination in challenging hospital environments such as operating rooms, intensive care units, and emergency departments. For more information, visit www.HAI-Solutions.com.

CONTACT: admin@hai-solutions.com

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SOURCE HAI Solutions INC