Not Cleared Direct

DEN180024 - Leica FL400 (FDA 510(k) Clearance)

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

DEN180024 · Leica Microsystems (Schweiz) AG · Neurology device
Mar 2019
Decision
335d
Days
Class 2
Risk

DEN180024 is an FDA 510(k) submission (not cleared) for the Leica FL400. Classified as Diagnostic Neurosurgical Microscope Filter (product code QFX), Class II - Special Controls.

Submitted by Leica Microsystems (Schweiz) AG (Heerbrugg, CH). The FDA issued a Not Cleared (DENG) decision on March 28, 2019 after a review of 335 days.

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 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 335 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.

Submission Details

510(k) Number DEN180024 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 27, 2018
Decision Date March 28, 2019
Days to Decision 335 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 163d · This submission: 335d
Pathway characteristics

Device Classification

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.