Not Cleared Direct

DEN140040 - Nautilus BrainPulse 1000 (FDA 510(k) Clearance)

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

DEN140040 · Jan Medical, Inc. · Neurology device
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Aug 2016
Decision
587d
Days
Class 2
Risk

DEN140040 is an FDA 510(k) submission (not cleared) for the Nautilus BrainPulse 1000. Classified as Cranial Motion Measurement Device (product code POP), Class II - Special Controls.

Submitted by Jan Medical, Inc. (Mountain View, US). The FDA issued a Not Cleared (DENG) decision on August 1, 2016 after a review of 587 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1630 - 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 587 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.

View all Jan Medical, Inc. devices

Submission Details

510(k) Number DEN140040 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 23, 2014
Decision Date August 01, 2016
Days to Decision 587 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
439d slower than avg
Panel avg: 148d · This submission: 587d
Pathway characteristics

Device Classification

Product Code POP Cranial Motion Measurement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1630
Definition A Cranial Motion Measurement Device Is A Prescription Device That Utilizes Accelerometers To Measure The Motion Or Acceleration Of The Skull. These Measurements Are Not To Be Used For Diagnostic Purposes.
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.