Not Cleared Direct

DEN190026 - iTEAR Neurostimulator (FDA 510(k) Clearance)

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

DEN190026 · Olympic Ophthalmics, Inc. · Ophthalmic device
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May 2020
Decision
352d
Days
Class 2
Risk

DEN190026 is an FDA 510(k) submission (not cleared) for the iTEAR Neurostimulator. Classified as Electromechanical Tear Stimulator (product code QKV), Class II - Special Controls.

Submitted by Olympic Ophthalmics, Inc. (Issaquah, US). The FDA issued a Not Cleared (DENG) decision on May 1, 2020 after a review of 352 days.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5305 - 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 352 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 Olympic Ophthalmics, Inc. devices

Submission Details

510(k) Number DEN190026 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 15, 2019
Decision Date May 01, 2020
Days to Decision 352 days
Submission Type Direct
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
242d slower than avg
Panel avg: 110d · This submission: 352d
Pathway characteristics

Device Classification

Product Code QKV Electromechanical Tear Stimulator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5305
Definition This Device Type Is A Non-implantable Device Intended To Increase Tear Production Via Mechanical Stimulation.
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 Ophthalmic devices follow this clearance model.