Cleared Special

K012011 - MODIFICATION TO A620 EEG

K012011 is an FDA 510(k) clearance for MODIFICATION TO A620 EEG, manufactured by Stoelting Co.. The device is a Class 2 Neurology device with product code HCC cleared through the Special 510(k) pathway after a 104-day FDA review.

K012011 · Stoelting Co. · Neurology device
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Oct 2001
Decision
104d
Days
Class 2
Risk

K012011 is an FDA 510(k) clearance for the MODIFICATION TO A620 EEG. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Stoelting Co. (Wood Dale, US). The FDA issued a Cleared decision on October 10, 2001 after a review of 104 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stoelting Co. devices

FDA 510(k) Submission Details - K012011

510(k) Number K012011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2001
Decision Date October 10, 2001
Days to Decision 104 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 148d · This submission: 104d
Pathway characteristics
Modification to existing cleared device.

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 43
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K012011.
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
NEUROCOMP
K993654 · Neurocybernetics · Jan 2000
NORODYN 8000 SEMG SYSTEM, ND-8000
K992439 · Myotronics-Noromed, Inc. · Aug 1999
INSIGHT MILLENNIUM
K990778 · Fasstech · Jun 1999