Cleared Traditional

K925636 - AHMED GLAUCOMA VALVE IMPLANT

K925636 is an FDA 510(k) clearance for AHMED GLAUCOMA VALVE IMPLANT, manufactured by New World Medical, Inc.. The device is a Class 2 Ophthalmic device with product code KYF cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K925636 · New World Medical, Inc. · Ophthalmic device
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Nov 1993
Decision
368d
Days
Class 2
Risk

K925636 is an FDA 510(k) clearance for the AHMED GLAUCOMA VALVE IMPLANT. Classified as Implant, Eye Valve (product code KYF), Class II - Special Controls.

Submitted by New World Medical, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on November 12, 1993 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 New World Medical, Inc. devices

FDA 510(k) Submission Details - K925636

510(k) Number K925636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1992
Decision Date November 12, 1993
Days to Decision 368 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
258d slower than avg
Panel avg: 110d · This submission: 368d
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.