Not Cleared Direct

DEN160030 - Oculeve Intranasal Tear Neurostimulator Device (FDA 510(k) Clearance)

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

DEN160030 · Oculeve, Inc. · Ophthalmic device
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Apr 2017
Decision
291d
Days
Class 2
Risk

DEN160030 is an FDA 510(k) submission (not cleared) for the Oculeve Intranasal Tear Neurostimulator Device. Classified as Intranasal Electrostimulation Device (product code PQJ), Class II - Special Controls.

Submitted by Oculeve, Inc. (South San Francisco, US). The FDA issued a Not Cleared (DENG) decision on April 24, 2017 after a review of 291 days.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5300 - 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. Elevated predicate reliance profile. With 291 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 Oculeve, Inc. devices

Submission Details

510(k) Number DEN160030 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 07, 2016
Decision Date April 24, 2017
Days to Decision 291 days
Submission Type Direct
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 110d · This submission: 291d
Pathway characteristics

Device Classification

Product Code PQJ Intranasal Electrostimulation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5300
Definition This Device Type Is Intended To Temporarily Increase Tear Production Using Neurostimulation In Adult Patients.
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.