Cleared Traditional

K090019 - NATUS NEUROWORKS, MODEL 104196

K090019 is an FDA 510(k) clearance for NATUS NEUROWORKS, manufactured by Natus Medical, Inc.. The device is a Class 2 Neurology device with product code OMB cleared through the Traditional 510(k) pathway after a 416-day FDA review.

K090019 · Natus Medical, Inc. · Neurology device
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Feb 2010
Decision
416d
Days
Class 2
Risk

K090019 is an FDA 510(k) clearance for the NATUS NEUROWORKS, MODEL 104196. Classified as Automatic Event Detection Software For Full-montage Electroencephalograph (product code OMB), Class II - Special Controls.

Submitted by Natus Medical, Inc. (Oakville, CA). The FDA issued a Cleared decision on February 22, 2010 after a review of 416 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Natus Medical, Inc. devices

FDA 510(k) Submission Details - K090019

510(k) Number K090019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2009
Decision Date February 22, 2010
Days to Decision 416 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
268d slower than avg
Panel avg: 148d · This submission: 416d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMB Device Classification - Class 2, Special Controls

Product Code OMB Automatic Event Detection Software For Full-montage Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Or Identify Electroencephalograph Waveforms For Spikes, Electrographic Seizures, Seizure-like Events In Order To Aid In Identification Of Such Events And Help Review And Annotation Of Prolonged Eeg Traces; All Output Subject To Verification By 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 - OMB Automatic Event Detection Software For Full-montage Electroencephalograph

All 34
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