# DEN250004: QIKCAP System

- Pathway: De Novo (Direct)
- Applicant: Hai Solutions
- Decided: Dec 23, 2025 after 327 days
- Product code: SGX (Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves)
- Device class: 2
- Regulation: 21 CFR 880.6512
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The HAI Solutions QIKCAP Device, used in conjunction with the single-use QIKCAP Cap, is a UVC treatment device intended to supplement manual needle-free luer connector instructions to 'scrub the hub' with CHG/IPA wipes. After conducting the protocol in the needle-free connector instructions for use, the QIKCAP Device applies UVC to the connector septum for 10 seconds to assist in reducing microbial contamination. The single use QIKCAP Cap also functions as a physical barrier, helping protect the connector from environmental contamination for up to 7 days if not removed. Under the conditions of testing, the combined use of an 3.15% CHG/70% IPA wipes applied for a 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.

Source page: https://510kreport.com/device/DEN250004
Methodology: https://510kreport.com/methodology