FDA granted HAI Solutions' De Novo request for the QIKCAP System on December 23. DEN250004 creates a new Class II regulation, 21 CFR 880.6512, for ultraviolet light-based microbial reduction devices for luer-activated valves, product code SGX. FDA received the request on January 30, a 327-day review. The Carlsbad company announced the grant on December 30.
The system pairs a handheld UVC device with a single-use cap. Ten seconds of UVC on a needleless connector follows a standard 3.15% chlorhexidine and 70% isopropyl alcohol wipe. The cap then shields the connector for up to seven days. Bench testing showed 4-log reductions of Staphylococcus aureus, Klebsiella pneumoniae, Staphylococcus epidermidis and Enterobacter cloacae. The labeling notes no significant reduction of fungi and no established link to infection rates; the device supplements manual disinfection rather than replacing it.
CEO Nick Perrenoud leads a small team. CB Insights lists about $500,000 raised from angel groups including NuFund Venture Group and TCA Venture Group. A De Novo on angel money is rare. The reward is a regulation written around your device, and a predicate every competitor will have to cite.