De Novo · Granted
GrantedQIKCAP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hai Solutions · SGX Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves
Granted on Dec 23, 2025 as a new device type through De Novo after a 327-day review.
- Decided
- Dec 23, 2025
- Review
- 327 days
- Class
- Class II
- Product code
- SGX
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SGX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SGX devicesSGX Ultraviolet Light-Based Microbial Reduction Device For Luer-Activated Valves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SGX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SGX
Too few SGX 510(k)s in any year since 2007 to give a median.
Recalls per year · SGX
No recall names SGX since 2007.
Adverse event reports per year · SGX
No MAUDE report names SGX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (146 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250004 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250004: QIKCAP System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250004
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026