Cleared Special

K172743 - Natus VikingQuest (FDA 510(k) Clearance)

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

K172743 · Natus Neurology Incorporated · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 2017
Decision
98d
Days
Class 2
Risk

K172743 is an FDA 510(k) clearance for the Natus VikingQuest. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Natus Neurology Incorporated (Middleton, US). The FDA issued a Cleared decision on December 19, 2017 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Natus Neurology Incorporated devices

Submission Details

510(k) Number K172743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2017
Decision Date December 19, 2017
Days to Decision 98 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 148d · This submission: 98d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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.