Cleared Abbreviated

HARMONIE SYSTEM (K083577) - FDA 510(k) Clearance

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

K083577 · Stellate Systems · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
999d
Days
Class 2
Risk

K083577 is an FDA 510(k) clearance for the HARMONIE SYSTEM. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Stellate Systems (Montreal, Quebec, CA). The FDA issued a Cleared decision on August 29, 2011 after a review of 999 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Stellate Systems devices

Submission Details

510(k) Number K083577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2008
Decision Date August 29, 2011
Days to Decision 999 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
851d slower than avg
Panel avg: 148d · This submission: 999d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GWQ Full-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 Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations
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 - GWQ Full-montage Standard Electroencephalograph

All 187
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