Not Cleared Direct

DEN250002 - Delphi-MD System (FDA 510(k) Clearance)

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

DEN250002 · Quantalx Neuroscience, Ltd. · Neurology device
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Aug 2025
Decision
229d
Days
Class 2
Risk

DEN250002 is an FDA 510(k) submission (not cleared) for the Delphi-MD System. Classified as Non-invasive Evoked Response Brain Stimulator (product code SFN), Class II - Special Controls.

Submitted by Quantalx Neuroscience, Ltd. (Kfar-Saba, IL). The FDA issued a Not Cleared (DENG) decision on August 20, 2025 after a review of 229 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1860 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Neurology review framework.

View all Quantalx Neuroscience, Ltd. devices

Submission Details

510(k) Number DEN250002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 03, 2025
Decision Date August 20, 2025
Days to Decision 229 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 148d · This submission: 229d
Pathway characteristics

Device Classification

Product Code SFN Non-invasive Evoked Response Brain Stimulator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1860
Definition A Non-invasive Evoked Response Brain Stimulator Is A Non-penetrating Device Used To Apply A Stimulus To The Brain For The Purpose Of Measuring The Evoked Brain Activity Response.
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.