Not Cleared Direct

DEN130039 - BRAINPORT V100 DEVICE (FDA 510(k) Clearance)

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

DEN130039 · Wicab, Inc. · Ophthalmic device
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Jun 2015
Decision
680d
Days
Class 2
Risk

DEN130039 is an FDA 510(k) submission (not cleared) for the BRAINPORT V100 DEVICE. Classified as Oral Electronic Vision Aid (product code PIC), Class II - Special Controls.

Submitted by Wicab, Inc. (Philedelphia, US). The FDA issued a Not Cleared (DENG) decision on June 18, 2015 after a review of 680 days.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5905 - 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 680 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 Wicab, Inc. devices

Submission Details

510(k) Number DEN130039 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 07, 2013
Decision Date June 18, 2015
Days to Decision 680 days
Submission Type Direct
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
570d slower than avg
Panel avg: 110d · This submission: 680d
Pathway characteristics

Device Classification

Product Code PIC Oral Electronic Vision Aid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5905
Definition To Use As An Oral Electronic Vision Aid In Conjunction With Other Assistive Devices (e.g., The White Cane, Guide Dog, Etc.)
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.