Cleared Traditional

K110967 - ENTERPRISE ELECTROPHYSIOLOGY SYSTEM (FDA 510(k) Clearance)

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

K110967 · Neuralynx, Inc. · Neurology device
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Jun 2011
Decision
85d
Days
Class 2
Risk

K110967 is an FDA 510(k) clearance for the ENTERPRISE ELECTROPHYSIOLOGY SYSTEM. Classified as Reduced- Montage Standard Electroencephalograph (product code OMC), Class II - Special Controls.

Submitted by Neuralynx, Inc. (Bozeman, US). The FDA issued a Cleared decision on June 30, 2011 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neuralynx, Inc. devices

Submission Details

510(k) Number K110967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2011
Decision Date June 30, 2011
Days to Decision 85 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
63d faster than avg
Panel avg: 148d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMC Reduced- Montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes
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.

Regulatory Peers - OMC Reduced- Montage Standard Electroencephalograph

All 27
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