Cleared Traditional

K012852 - EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS

K012852 is an FDA 510(k) clearance for EX-PRESS MINATURE GLAUCOMA IMPLANT, manufactured by Optonol, Ltd.. The device is a Class 2 Ophthalmic device with product code KYF cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K012852 · Optonol, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
214d
Days
Class 2
Risk

K012852 is an FDA 510(k) clearance for the EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS. Classified as Implant, Eye Valve (product code KYF), Class II - Special Controls.

Submitted by Optonol, Ltd. (Rockville, US). The FDA issued a Cleared decision on March 26, 2002 after a review of 214 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 Optonol, Ltd. devices

FDA 510(k) Submission Details - K012852

510(k) Number K012852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2001
Decision Date March 26, 2002
Days to Decision 214 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
104d slower than avg
Panel avg: 110d · This submission: 214d
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 12
Devices cleared under the same product code (KYF) and FDA review panel - the closest regulatory comparables to K012852.
AHMED ClearPath Glaucoma Drainage Device
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AHMED GLAUCOMA VALVE IMPLANT
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AHMED GLAUCOMA VALVE, MODEL S3
K980657 · New World Medical, Inc. · Apr 1998
BAERVELT PARS PLANA GLAUCOMA IMPLANT
K955455 · Pharmacia Iovision, Inc. · Feb 1997