Cleared Traditional

K882599 - NICOLET BRAINLAB SYSTEM

K882599 is an FDA 510(k) clearance for NICOLET BRAINLAB SYSTEM, manufactured by Nicolet Instrument Corp.. The device is a Class 2 Neurology device with product code GWK cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K882599 · Nicolet Instrument Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1988
Decision
117d
Days
Class 2
Risk

K882599 is an FDA 510(k) clearance for the NICOLET BRAINLAB SYSTEM. Classified as Conditioner, Signal, Physiological (product code GWK), Class II - Special Controls.

Submitted by Nicolet Instrument Corp. (Madison, US). The FDA issued a Cleared decision on October 19, 1988 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1845 - 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 Nicolet Instrument Corp. devices

FDA 510(k) Submission Details - K882599

510(k) Number K882599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1988
Decision Date October 19, 1988
Days to Decision 117 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 148d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWK Device Classification - Class 2, Special Controls

Product Code GWK Conditioner, Signal, Physiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1845
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 - GWK Conditioner, Signal, Physiological

All 7
Devices cleared under the same product code (GWK) and FDA review panel - the closest regulatory comparables to K882599.
VITALSENSE XHR
K061870 · Respironics, Inc. · Aug 2006
ACTIHEART
K052489 · Respironics, Inc. · Sep 2005
NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300
K905594 · Nihon Kohden America, Inc. · Jun 1991
BIO-LOGIC BANKER
K872290 · Bio-Logic Systems Corp. · Oct 1987
NEUROPACK 8 MEE 4108
K841497 · Nihon Kohden America, Inc. · Jun 1984
EVOKED RESPONSE STIMULATORS
K803226 · Bio-Logic Systems Corp. · Feb 1981