Cleared Traditional

K993654 - NEUROCOMP

K993654 is an FDA 510(k) clearance for NEUROCOMP, manufactured by Neurocybernetics. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K993654 · Neurocybernetics · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
90d
Days
Class 2
Risk

K993654 is an FDA 510(k) clearance for the NEUROCOMP. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Neurocybernetics (Great Neck, US). The FDA issued a Cleared decision on January 27, 2000 after a review of 90 days - within the typical 510(k) review window.

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: 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 Neurocybernetics devices

FDA 510(k) Submission Details - K993654

510(k) Number K993654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1999
Decision Date January 27, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
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 K993654.
POLYGRAM NET BIOFEEDBACK APPLICATION
K041244 · Medtronic Vascular · Aug 2004
SONDREX P.A.L. SYSTEM
K010388 · Ohmeda Medical · Dec 2001
EAR MUFFINS
K012384 · Bio-Logic Systems Corp. · Oct 2001
NORODYN 8000 SEMG SYSTEM, ND-8000
K992439 · Myotronics-Noromed, Inc. · Aug 1999
INSIGHT MILLENNIUM
K990778 · Fasstech · Jun 1999
BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
K990538 · Brainmaster · May 1999