Cleared Traditional

K990538 - BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE

K990538 is an FDA 510(k) clearance for BRAINMASTER 2E MODULE AND SOFTWARE BIOF..., manufactured by Brainmaster. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K990538 · Brainmaster · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
89d
Days
Class 2
Risk

K990538 is an FDA 510(k) clearance for the BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Brainmaster (Great Neck, US). The FDA issued a Cleared decision on May 19, 1999 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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.

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FDA 510(k) Submission Details - K990538

510(k) Number K990538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1999
Decision Date May 19, 1999
Days to Decision 89 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 148d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - HCC Device, Biofeedback

All 42
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K990538.
NEUROCOMP
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INSIGHT MILLENNIUM
K990778 · Fasstech · Jun 1999
THE BAGNOLI-8 EMG SYSTEM
K990356 · Delsys, Inc. · Apr 1999
XYZ SYSTEM
K983550 · Bio-Monitoring International Corp. · Jan 1999
THE BAGNOLI-4 EMG SYSTEM
K981934 · Delsys, Inc. · Aug 1998