Not Cleared Direct

Modius Spero (DEN250013) - FDA 510(k) Clearance

DEN250013 · Neurovalens Limited · Neurology device
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May 2026
Decision
387d
Days
-
Risk

DEN250013 is an FDA 510(k) submission (not cleared) for the Modius Spero.

Submitted by Neurovalens Limited (Portglenone, GB). The FDA issued a Not Cleared (DENG) decision on May 8, 2026 after a review of 387 days.

This device falls under the Neurology FDA review panel. 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 387 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 DEN250013 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 16, 2025
Decision Date May 08, 2026
Days to Decision 387 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 148d · This submission: 387d
Pathway characteristics

Device Classification

Product Code SHX
Device Class -