HAI Solutions, a company focused on ultraviolet (UVC) microbial reduction technologies for healthcare settings, announced that the US Food and Drug Administration (FDA) has granted De Novo classification to its QIKCAP System. The decision establishes the first FDA-recognised Class II medical device category for an ultraviolet light–based microbial reduction device designed specifically for luer-activated valves.

The QIKCAP System consists of a reusable QIKCAP Device and a single-use QIKCAP Cap, developed to complement existing manual disinfection practices for needle-free luer connectors used in intravascular applications. The QIKCAP Device delivers targeted UVC irradiation to the connector septum, achieving microbial reduction within 10 seconds. The QIKCAP Cap acts as a physical barrier, protecting the connector from environmental contamination for up to seven days when not in use.

With this regulatory milestone, HAI Solutions strengthens its position in the UVC medical device segment. The company continues to expand its technology portfolio, including a strategic collaboration with Intellego Technologies to develop a chromatic dosimeter tailored for UVC healthcare applications. HAI Solutions has consistently advocated for robust FDA oversight of UVC-based medical devices to ensure safety, quality, and clinical reliability.

“This De Novo classification represents a major achievement for our team,” said Nick Perrenoud, chief executive officer of HAI Solutions. “The QIKCAP System addresses a critical gap in IV connector maintenance and protection, and we are proud to bring a regulated UVC solution to the market.”

HAI Solutions worked closely with the FDA throughout the De Novo review process, complying with both general and special controls that required extensive performance testing under worst-case conditions. In laboratory testing, the combined use of 3.15% chlorhexidine gluconate (CHG) and 70% isopropyl alcohol wipes for five seconds followed by the QIKCAP Device resulted in a 4-log reduction of bacteria, including Staphylococcus aureus, Klebsiella pneumoniae, Staphylococcus epidermidis, and Enterobacter cloacae. The device did not demonstrate significant reduction of fungal organisms, and a direct correlation to clinical infection outcomes has not yet been established.

Headquartered in Carlsbad, California, HAI Solutions is developing a comprehensive range of intravenous therapy solutions aimed at reducing IV contamination risks in high-acuity hospital environments such as operating rooms, intensive care units, and emergency departments.