Cleared Traditional

K033543 - NARCOTREND, MODEL COMPACT 4.0

K033543 is an FDA 510(k) clearance for NARCOTREND, manufactured by Mt Monitortechnik GmbH & Co. KG. The device is a Class 2 Neurology device with product code OLW cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K033543 · Mt Monitortechnik GmbH & Co. KG · Neurology device
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Optimized for regulatory review, auditing and printing
Sep 2004
Decision
312d
Days
Class 2
Risk

K033543 is an FDA 510(k) clearance for the NARCOTREND, MODEL COMPACT 4.0. Classified as Index-generating Electroencephalograph Software (product code OLW), Class II - Special Controls.

Submitted by Mt Monitortechnik GmbH & Co. KG (Bad Bramstedt, DE). The FDA issued a Cleared decision on September 17, 2004 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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. Elevated predicate reliance profile. 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 Mt Monitortechnik GmbH & Co. KG devices

FDA 510(k) Submission Details - K033543

510(k) Number K033543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2003
Decision Date September 17, 2004
Days to Decision 312 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 148d · This submission: 312d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLW Device Classification - Class 2, Special Controls

Product Code OLW Index-generating Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electrical Activity Of The Brain By Transformation Of Electroencephalograph Signals Into A Dimensionless Index Number For Use And Interpretation By A Qualified User.
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 - OLW Index-generating Electroencephalograph Software

All 34
Devices cleared under the same product code (OLW) and FDA review panel - the closest regulatory comparables to K033543.
SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET
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K052145 · Ge Healthcare · Aug 2005
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K050835 · Ge Healthcare · May 2005
BISX
K040183 · Aspect Medical Systems, Inc. · Feb 2004
SEDLINE WITH FRONTAL PSI
K033999 · Physiometrix, Inc. · Feb 2004
EEG MONITOR WITH BIS, MODEL A-2000
K030267 · Aspect Medical Systems, Inc. · Jan 2004