Cleared Traditional

K172892 - Neuro Assessment System NAS-1000 (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172892 · Headsense Medical, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2018
Decision
167d
Days
Class 2
Risk

K172892 is an FDA 510(k) clearance for the Neuro Assessment System NAS-1000. Classified as Cranial Sound Monitor (product code QBE), Class II - Special Controls.

Submitted by Headsense Medical, Inc. (Akron, US). The FDA issued a Cleared decision on March 8, 2018 after a review of 167 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1875 - 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.

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Submission Details

510(k) Number K172892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2017
Decision Date March 08, 2018
Days to Decision 167 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
19d slower than avg
Panel avg: 148d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QBE Cranial Sound Monitor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
Definition To Non-invasively Detect, Monitor, Record And Display Acoustic Signals In The Brain.
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.