Cleared Traditional

K902296 - TRABECULO-SUPRACHOROIDAL SHUNT

K902296 is an FDA 510(k) clearance for TRABECULO-SUPRACHOROIDAL SHUNT, manufactured by Visionex, Inc.. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K902296

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.

KYF Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KYF Implant, Eye Valve

All 16
Devices cleared under the same product code (KYF) and FDA review panel - the closest regulatory comparables to K902296.
AHMED GLAUCOMA VALVE, MODEL S3
K980657 · New World Medical, Inc. · Apr 1998
BAERVELT PARS PLANA GLAUCOMA IMPLANT
K955455 · Pharmacia Iovision, Inc. · Feb 1997
KRUPIN EYE VALVE WITH DISK
K905703 · Hood Laboratories · Mar 1991
KRUPIN EYE VALVE W/SCLERAL BUCKLE
K885125 · Hood Laboratories · Jan 1989
MOLTENO VALVE SETON
K875099 · Staar Surgical Co. · Mar 1988