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Ahmed Glaucoma Valve Implant

by New World Medical, Inc. 2 variants

510(k) K925636

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K925636↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK925636 Date12 Nov 1993ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 Sep 2026

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

The Ahmed Glaucoma Valve Implant is a drainage device classified as an Eye Valve Implant under the FDA’s nomenclature. It is designed to manage intraocular pressure in glaucoma by providing a controlled outflow pathway for aqueous humor, reducing pressure within the eye while minimizing the risk of excessive drainage-related complications.

This device is implanted during a single-stage surgical procedure and is constructed from medical-grade silicone. It is intended for use in ophthalmic settings and is supplied sterile for single-use. The implant’s design eliminates the need for drainage tube ligatures or occluding sutures, facilitating easier insertion and reducing postoperative complications. Authorized under FDA 510K and MDD, it adheres to regulatory standards for Class II medical devices.

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 World's Leading Glaucoma Drainage Device Designed to Prevent Excessive Drainage The tapered profile of the Ahmed® Glaucoma Valve helps facilitate insertion of the device. The plate body is made of medical grade silicon and the unique valve system is designed to prevent excessive drainage and chamber collapse.

Source: newworldmedical.com

Manufacturer's product page: Ahmed® Glaucoma Valve

Other devices from New World Medical, Inc.

See all devices from New World Medical, Inc. →

Questions

AI-generated answers, 18 Sep 2026

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

  • What is the Ahmed Glaucoma Valve Implant primarily used for in clinical practice?

    The Ahmed Glaucoma Valve Implant is designed to manage intraocular pressure in patients with glaucoma by providing a controlled drainage pathway for aqueous humor. This helps reduce eye pressure while minimizing complications from excessive drainage, making it suitable for single-stage surgical procedures in ophthalmic settings.

  • Is the Ahmed Glaucoma Valve Implant intended for reuse or is it single-use only?

    The Ahmed Glaucoma Valve Implant is supplied sterile and intended for single-use only. This ensures patient safety and reduces the risk of infection or contamination associated with reuse.

  • What materials is the Ahmed Glaucoma Valve Implant made from, and how does this affect its use?

    The implant is constructed from medical-grade silicone, a material known for its biocompatibility and durability. This construction allows for long-term implantation without adverse tissue reactions, while also enabling easier surgical insertion due to its flexible yet sturdy design.

  • How many different sizes or models of the Ahmed Glaucoma Valve Implant are available?

    The Ahmed Glaucoma Valve Implant comes in multiple sizes, as indicated by the diverse registration numbers (e.g., 3015217553, 3001227772, etc.) in the OpenFDA database. These variations allow surgeons to select the appropriate size based on patient anatomy and clinical needs.

  • What regulatory pathways does the Ahmed Glaucoma Valve Implant follow, and what does this mean for its use?

    The device is authorized under both the FDA’s 510(k) pathway (traditional clearance, classified as substantially equivalent) and the MDD (Medical Device Directive). This means it has undergone review by regulatory bodies to confirm its safety and effectiveness for managing intraocular pressure in glaucoma patients, adhering to Class II medical device standards.