Cleared Traditional

K254030 - cCeLL405

K254030 is an FDA 510(k) clearance for cCeLL405, manufactured by VPIX Medical, Inc.. The device is a Class 2 Neurology device with product code QFX cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K254030 · VPIX Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
290d
Days
Class 2
Risk

K254030 is an FDA 510(k) clearance for the cCeLL405. Classified as Diagnostic Neurosurgical Microscope Filter (product code QFX), Class II - Special Controls.

Submitted by VPIX Medical, Inc. (Daejeon, KR). The FDA issued a Cleared decision on October 2, 2026 after a review of 290 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4950 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all VPIX Medical, Inc. devices

FDA 510(k) Submission Details - K254030

510(k) Number K254030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2025
Decision Date October 02, 2026
Days to Decision 290 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 149d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QFX Device Classification - Class 2, Special Controls

Product Code QFX Diagnostic Neurosurgical Microscope Filter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4950
Definition A Diagnostic Neurosurgical Microscope Filter Is A Device Intended For Use During Neurosurgery To Visualize Fluorescence And Enhance Visualization Of Tissue Associated With A Specific Disease Or Condition.
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 Neurology devices follow this clearance model.

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