Not Cleared Direct

DEN140022 - GLAUCOMA COMPANION (FDA 510(k) Clearance)

Class I Ophthalmic device.

DEN140022 · Innovatex, Inc. · Ophthalmic device
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Apr 2016
Decision
642d
Days
Class 1
Risk

DEN140022 is an FDA 510(k) submission (not cleared) for the GLAUCOMA COMPANION. Classified as Tear Duct Occluder (product code PLX), Class I - General Controls.

Submitted by Innovatex, Inc. (Weston, US). The FDA issued a Not Cleared (DENG) decision on April 20, 2016 after a review of 642 days.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5838 - the FDA ophthalmic 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 642 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 Innovatex, Inc. devices

Submission Details

510(k) Number DEN140022 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 18, 2014
Decision Date April 20, 2016
Days to Decision 642 days
Submission Type Direct
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
532d slower than avg
Panel avg: 110d · This submission: 642d
Pathway characteristics

Device Classification

Product Code PLX Tear Duct Occluder
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5838
Definition A Nasolacrimal Compression Device Is A Device Used To Compress The Nasolacrimal Ducts To Reduce Drainage By Means Of Temporary Occlusion Of The Nasolacrimal System. The Device May Include A Nose Piece Attached To A Frame To Apply Pressure To The Duct.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.