Cleared Traditional

K171451 - Ahmed Glaucoma Valve Model FP8 (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171451 · New World Medical, Inc. · Ophthalmic device
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Aug 2017
Decision
83d
Days
Class 2
Risk

K171451 is an FDA 510(k) clearance for the Ahmed Glaucoma Valve Model FP8. 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 August 8, 2017 after a review of 83 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all New World Medical, Inc. devices

Submission Details

510(k) Number K171451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2017
Decision Date August 08, 2017
Days to Decision 83 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
27d faster than avg
Panel avg: 110d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.