Cleared Traditional

K060644 - AHMED GLAUCOMA VALVE

K060644 is an FDA 510(k) clearance for AHMED GLAUCOMA VALVE, 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 192-day FDA review.

K060644 · New World Medical, Inc. · Ophthalmic device
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Sep 2006
Decision
192d
Days
Class 2
Risk

K060644 is an FDA 510(k) clearance for the AHMED GLAUCOMA VALVE, MODEL M4. 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 September 18, 2006 after a review of 192 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 New World Medical, Inc. devices

FDA 510(k) Submission Details - K060644

510(k) Number K060644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2006
Decision Date September 18, 2006
Days to Decision 192 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
82d slower than avg
Panel avg: 110d · This submission: 192d
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.