DEN250004 is an FDA 510(k) submission for the QIKCAP System. This device is classified as a Ultraviolet Light-based Microbial Reduction Device For Luer-activated Valves (Class II - Special Controls, product code SGX).
Submitted by Hai Solutions (Carlsbad, US). The FDA issued a Not Cleared (DENG) decision on December 23, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6512. An Ultraviolet Light-based Microbial Reduction Device For Luer-activated Valves Is A Device That Uses Ultraviolet Light To Irradiate Luer-activated Valves (e.g., As Used For Intravascular Administration). The Device Is Intended To Supplement The Manual, Physical Microbicidal Treatment Of Luer-activated Valves By Providing Limited Microbial Reduction, And Is Not Intended To Disinfect Or Replace Manual Microbicidal Treatment..
| 510(k) Number | DEN250004 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | January 30, 2025 |
| Decision Date | December 23, 2025 |
| Days to Decision | 327 days |
| Submission Type | Direct |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | SGX - Ultraviolet Light-based Microbial Reduction Device For Luer-activated Valves |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6512 |
| Definition | An Ultraviolet Light-based Microbial Reduction Device For Luer-activated Valves Is A Device That Uses Ultraviolet Light To Irradiate Luer-activated Valves (e.g., As Used For Intravascular Administration). The Device Is Intended To Supplement The Manual, Physical Microbicidal Treatment Of Luer-activated Valves By Providing Limited Microbial Reduction, And Is Not Intended To Disinfect Or Replace Manual Microbicidal Treatment. |