Cleared Traditional

ENVOY PATIENT MONITOR (K024245) - FDA 510(k) Clearance

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

K024245 · Mennen Medical , Ltd. · Neurology device
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May 2004
Decision
504d
Days
Class 2
Risk

K024245 is an FDA 510(k) clearance for the ENVOY PATIENT MONITOR. Classified as Reduced- Montage Standard Electroencephalograph (product code OMC), Class II - Special Controls.

Submitted by Mennen Medical , Ltd. (Rohovot, IL). The FDA issued a Cleared decision on May 10, 2004 after a review of 504 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 Mennen Medical , Ltd. devices

Submission Details

510(k) Number K024245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2002
Decision Date May 10, 2004
Days to Decision 504 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
356d slower than avg
Panel avg: 148d · This submission: 504d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMC Reduced- Montage Standard Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes
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.