Cleared Traditional

K915820 - NEUROSEARCH-24 OR NRS-24

K915820 is an FDA 510(k) clearance for NEUROSEARCH-24 OR NRS-24, manufactured by Lexicor Medical Technology, Inc.. The device is a Class 2 Neurology device with product code OLT cleared through the Traditional 510(k) pathway after a 1136-day FDA review.

K915820 · Lexicor Medical Technology, Inc. · Neurology device
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Feb 1995
Decision
1136d
Days
Class 2
Risk

K915820 is an FDA 510(k) clearance for the NEUROSEARCH-24 OR NRS-24. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Lexicor Medical Technology, Inc. (Boulder, US). The FDA issued a Cleared decision on February 8, 1995 after a review of 1136 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 Lexicor Medical Technology, Inc. devices

FDA 510(k) Submission Details - K915820

510(k) Number K915820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1991
Decision Date February 08, 1995
Days to Decision 1136 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
988d slower than avg
Panel avg: 148d · This submission: 1136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLT Device Classification - Class 2, Special Controls

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For 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 - OLT Non-normalizing Quantitative Electroencephalograph Software

All 31
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