Cleared Traditional

K902296 - TRABECULO-SUPRACHOROIDAL SHUNT

K902296 is the FDA 510(k) clearance for TRABECULO-SUPRACHOROIDAL SHUNT by Visionex, Inc.. It is a Class 2 Ophthalmic device (product code KYF) cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K902296 · Visionex, Inc. · Ophthalmic device
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Mar 1991
Decision
296d
Days
Class 2
Risk

K902296 is an FDA 510(k) clearance for the TRABECULO-SUPRACHOROIDAL SHUNT. Classified as Implant, Eye Valve (product code KYF), Class II - Special Controls.

Submitted by Visionex, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 14, 1991 after a review of 296 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3920 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Visionex, Inc. devices

Submission Details

510(k) Number K902296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1990
Decision Date March 14, 1991
Days to Decision 296 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 110d · This submission: 296d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KYF Implant, Eye Valve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3920
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.