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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 149d · 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 143
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K012011.
SONDREX P.A.L. SYSTEM
K010388 · Ohmeda Medical · Dec 2001
MODEL MES-9000/EMG SYSTEM
K013399 · Myotronics-Noromed, Inc. · Nov 2001
EAR MUFFINS
K012384 · Bio-Logic Systems Corp. · Oct 2001
INSIGHT MILLENNIUM PLUS
K011964 · Fasstech · Sep 2001
BIOREHAB SYSTEM
K011823 · Nicolet Biomedical, Inc. · Sep 2001
INSIGHT GENESIS
K011983 · Fasstech · Aug 2001
K012011 · MODIFICATION TO A620 EEG
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