Cleared Special

K231051 - Ahmed® Glaucoma Valve Model FP8

K231051 is an FDA 510(k) clearance for Ahmed Glaucoma Valve Model FP8, manufactured by New World Medical, Inc.. The device is a Class 2 Ophthalmic device with product code KYF cleared through the Special 510(k) pathway after a 29-day FDA review.

K231051 · New World Medical, Inc. · Ophthalmic device
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May 2023
Decision
29d
Days
Class 2
Risk

K231051 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 May 12, 2023 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all New World Medical, Inc. devices

FDA 510(k) Submission Details - K231051

510(k) Number K231051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2023
Decision Date May 12, 2023
Days to Decision 29 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 110d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 16
Devices cleared under the same product code (KYF) and FDA review panel - the closest regulatory comparables to K231051.
Ahmed® Glaucoma Valve Model FP7
K230975 · New World Medical, Inc. · May 2023
iStent infinite Trabecular Micro-Bypass System, Model iS3
K220032 · Glaukos Corporation · Aug 2022
AHMED ClearPath Glaucoma Drainage Device
K182518 · New World Medical, Inc. · Jan 2019
Ahmed Glaucoma Valve Model FP8
K171451 · New World Medical, Inc. · Aug 2017
XEN Glaucoma Treatment System
K161457 · Allergan, Inc. · Nov 2016
Ahmed Glaucoma Valve
K162060 · New World Medical, Inc. · Oct 2016