Not Cleared Direct

DEN140033 - Companion (FDA 510(k) Clearance)

Class II Neurology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN140033 · Lgch, Inc. · Neurology device
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Feb 2017
Decision
829d
Days
Class 2
Risk

DEN140033 is an FDA 510(k) submission (not cleared) for the Companion. Classified as Physiological Signal Based Seizure Monitoring System (product code POS), Class II - Special Controls.

Submitted by Lgch, Inc. (San Antonio, US). The FDA issued a Not Cleared (DENG) decision on February 16, 2017 after a review of 829 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1580 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 829 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Lgch, Inc. devices

Submission Details

510(k) Number DEN140033 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 10, 2014
Decision Date February 16, 2017
Days to Decision 829 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
681d slower than avg
Panel avg: 148d · This submission: 829d
Pathway characteristics

Device Classification

Product Code POS Physiological Signal Based Seizure Monitoring System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1580
Definition The Physiological Signal Based Seizure Monitoring System Is A Prescription Device That Uses Physiological Signal To Identify Abnormal Physiological Activity That May Be Associated With A Seizure. The System Does Not Predict Seizure Onsets, And Is Not Intended As A Standalone Seizure Monitoring Device.
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.