Not Cleared Direct

DEN250004 - QIKCAP System (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN250004 · Hai Solutions · General Hospital
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Dec 2025
Decision
327d
Days
Class 2
Risk

DEN250004 is an FDA 510(k) submission (not cleared) for the QIKCAP System. Classified as Ultraviolet Light-based Microbial Reduction Device For Luer-activated Valves (product code SGX), Class II - Special Controls.

Submitted by Hai Solutions (Carlsbad, US). The FDA issued a Not Cleared (DENG) decision on December 23, 2025 after a review of 327 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6512 - the FDA general hospital device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 327 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 128d · This submission: 327d
Pathway characteristics

Device Classification

Product Code SGX Ultraviolet Light-based Microbial Reduction Device For Luer-activated Valves
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.