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Ahmed Glaucoma Valve Model FP8

by New World Medical, Inc.

510(k) K171451

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171451 Date8 Aug 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KYF
Device Class
Class II
Regulation
21 CFR Part 886.3920
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An implantable eye valve used for glaucoma drainage, the Ahmed Glaucoma Valve Model FP8 is a medical device designed to regulate intraocular pressure by facilitating the drainage of aqueous humor from the anterior chamber to an extraocular reservoir. It features a non-obstructive, self-regulating valve mechanism with a unique flow restrictor that helps control pressure and reduce the risk of hypotony at low pressures.

Supplied as a sterile, implantable device, the Ahmed Glaucoma Valve Model FP8 is intended for surgical placement in the eye to manage refractory glaucoma. It is manufactured from medical grade silicone and is authorized under FDA 510(k) clearance (K171451) as a Class II device under regulation number 886.3920, with product code KYF and ophthalmic specialty designation.

From the manufacturer

Ahmed® Glaucoma Valve is the world's leading glaucoma drainage device with a non-obstructive, self-regulating valve mechanism.

Source: newworldmedical.com

The Ahmed® Glaucoma Valve immediately reduces and controls pressure with its unique flow restrictor for all types of refractory glaucoma. This device also reduces the risk of hypotony at low pressures.

Source: newworldmedical.com

Manufacturer's product page: Ahmed® Glaucoma Valve

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