Cleared Traditional

K043009 - BRAINET KIT

K043009 is an FDA 510(k) clearance for BRAINET KIT, manufactured by Jordan Neuroscience, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K043009 · Jordan Neuroscience, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
72d
Days
Class 2
Risk

K043009 is an FDA 510(k) clearance for the BRAINET KIT. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Jordan Neuroscience, Inc. (San Bernardino, US). The FDA issued a Cleared decision on January 12, 2005 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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 Jordan Neuroscience, Inc. devices

FDA 510(k) Submission Details - K043009

510(k) Number K043009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2004
Decision Date January 12, 2005
Days to Decision 72 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
76d faster than avg
Panel avg: 148d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 221
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K043009.
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K041953 · Conmedcorp · Aug 2004
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K041670 · Aspect Medical Systems, Inc. · Jul 2004
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K032278 · Ambu, Inc. · Mar 2004