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AHMED ClearPath Glaucoma Drainage Device

by New World Medical, Inc.

510(k) K182518Ref CP250, CP350Model 250, 350

Active European Union and United States. Also listed in GUDID (US).

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) K182518↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00892064002348 Basic UDI-DI Date7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00892064002348 UDI-DI Date23 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK182518 Date18 Jan 2019ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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) · GUDID

Trade Name
Ahmed ClearPath EUDAMED
Ahmed™ ClearPath GUDID
Generic Name
Glaucoma shunt, tubular, non-animal-derived
Model / Ref / Catalog
250, 350, CP250, CP350
Primary DI / UDI-DI
00892064002348, 00892064002355
Basic UDI-DI
B-00892064002348, B-00892064002355
510(k) Number
FDA Product Code
KYF
EMDN Code
Q0208 Glaucoma drainages and kits
GMDN Term
Glaucoma shunt, tubular, non-animal-derived
Device Class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 886.3920
EU market of registration
Netherlands
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Area/Surface Area — 250 Square millimeter
Area/Surface Area — 350 Square millimeter

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

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 ClearPath Glaucoma Drainage Device is an Eye Valve Implant designed to manage intraocular pressure in patients with glaucoma. It functions as a non-penetrating shunt, providing an alternative drainage pathway for aqueous humor to reduce pressure within the eye while maintaining long-term stability.

This device is intended for surgical implantation in the anterior chamber of the eye and is supplied sterile for single-use. It is classified as a Class II medical device under FDA regulations and is authorized via 510(k) clearance and the Medical Device Directive (MDD). Multiple reference codes (e.g., 3015217553, 1000125279) correspond to its regulatory and registration filings in the U.S. and EU markets.

From the manufacturer

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 ClearPath Glaucoma Drainage Device used for in clinical practice?

    The Ahmed ClearPath Glaucoma Drainage Device is designed to manage intraocular pressure in patients with glaucoma by acting as a non-penetrating shunt. It provides an alternative drainage pathway for aqueous humor, helping to reduce eye pressure while maintaining long-term stability. This is particularly useful for patients who require surgical intervention to control glaucoma.

  • Is the Ahmed ClearPath Glaucoma Drainage Device intended for single-use or can it be reused?

    The Ahmed ClearPath Glaucoma Drainage Device is supplied sterile for single-use only. It is not designed for reuse, as this could compromise sterility and patient safety. Each device is intended for one surgical implantation in the anterior chamber of the eye.

  • What regulatory pathways has the Ahmed ClearPath Glaucoma Drainage Device followed for market authorization?

    The device has received FDA 510(k) clearance under the Traditional review pathway, with a decision classified as *Substantially Equivalent* to a predicate device. It is also authorized under the Medical Device Directive (MDD) in the EU, reflecting compliance with both U.S. and European regulatory requirements for Class II medical devices.

  • How should the Ahmed ClearPath Glaucoma Drainage Device be stored before use?

    Since the device is supplied sterile for single-use, it should be stored in its original packaging in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. Follow the manufacturer’s instructions for specific storage conditions to maintain sterility and device integrity until implantation.

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (14)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No