Cleared Abbreviated

K030350 - EXPRESS MINI GLAUCOMA SHUNT

K030350 is an FDA 510(k) clearance for EXPRESS MINI GLAUCOMA SHUNT, manufactured by Optonol, Ltd.. The device is a Class 2 Ophthalmic device with product code KYF cleared through the Abbreviated 510(k) pathway after a 38-day FDA review.

K030350 · Optonol, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
38d
Days
Class 2
Risk

K030350 is an FDA 510(k) clearance for the EXPRESS MINI GLAUCOMA SHUNT. Classified as Implant, Eye Valve (product code KYF), Class II - Special Controls.

Submitted by Optonol, Ltd. (Duluth, US). The FDA issued a Cleared decision on March 13, 2003 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3920 - the FDA ophthalmic device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Optonol, Ltd. devices

FDA 510(k) Submission Details - K030350

510(k) Number K030350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2003
Decision Date March 13, 2003
Days to Decision 38 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 110d · This submission: 38d
Pathway characteristics
Standards-based clearance path.

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 12
Devices cleared under the same product code (KYF) and FDA review panel - the closest regulatory comparables to K030350.
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AHMED GLAUCOMA VALVE IMPLANT
K991072 · New World Medical, Inc. · Jul 1999
AHMED GLAUCOMA VALVE, MODEL S3
K980657 · New World Medical, Inc. · Apr 1998
BAERVELT PARS PLANA GLAUCOMA IMPLANT
K955455 · Pharmacia Iovision, Inc. · Feb 1997