Cleared Traditional

WAVESTATE NEUROMONITOR (K092625) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K092625 · Wavestate, Inc. · Neurology device
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Jun 2010
Decision
306d
Days
Class 2
Risk

K092625 is an FDA 510(k) clearance for the WAVESTATE NEUROMONITOR. Classified as Burst Suppression Detection Software For Electroencephalograph (product code ORT), Class II - Special Controls.

Submitted by Wavestate, Inc. (Crofton, US). The FDA issued a Cleared decision on June 29, 2010 after a review of 306 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 Wavestate, Inc. devices

Submission Details

510(k) Number K092625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2009
Decision Date June 29, 2010
Days to Decision 306 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 148d · This submission: 306d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code ORT Burst Suppression Detection Software For Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Automatically Mark Or Identify Electroencephalograph Waveforms For Rhythmic Patterns Of Burst Suppression In Order To Aid In Identification Of Such Events And Help In The Review And Annotation Of Prolonged Eeg Traces; Software Can Also Quantify Simple Characteristics Of The Burst Suppression Such As Inter-burst Interval Or Count; 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.