Cleared Traditional

K152851 - BrainPort V100 (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152851 · Wicab, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
86d
Days
Class 2
Risk

K152851 is an FDA 510(k) clearance for the BrainPort V100. Classified as Oral Electronic Vision Aid (product code PIC), Class II - Special Controls.

Submitted by Wicab, Inc. (Middleton, US). The FDA issued a Cleared decision on December 24, 2015 after a review of 86 days - a notably fast clearance cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wicab, Inc. devices

Submission Details

510(k) Number K152851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2015
Decision Date December 24, 2015
Days to Decision 86 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 110d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.