Cleared Traditional

K093223 - COMPUMEDICS GRAEL SYSTEM

K093223 is an FDA 510(k) clearance for COMPUMEDICS GRAEL SYSTEM, manufactured by Compumedics Limited. The device is a Class 2 Neurology device with product code GWQ cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K093223 · Compumedics Limited · Neurology device
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Jan 2010
Decision
94d
Days
Class 2
Risk

K093223 is an FDA 510(k) clearance for the COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG. Classified as Full-montage Standard Electroencephalograph (product code GWQ), Class II - Special Controls.

Submitted by Compumedics Limited (Abbotsford, Victoria, AU). The FDA issued a Cleared decision on January 15, 2010 after a review of 94 days - within the typical 510(k) review window.

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: 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.

View all Compumedics Limited devices

FDA 510(k) Submission Details - K093223

510(k) Number K093223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2009
Decision Date January 15, 2010
Days to Decision 94 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
54d faster than avg
Panel avg: 148d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWQ Device Classification - Class 2, Special Controls

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 97
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