Product Code: KYF FDA class 2 21 CFR 886.3920

Implant, Eye Valve

Ophthalmic

The Eye Valve Implant is a surgically implanted ophthalmic device used to regulate intraocular pressure in patients with glaucoma who have not responded adequately to other treatments, by creating an alternative drainage pathway for aqueous humor. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KYF, regulated under 21 CFR 886.3920, in the Ophthalmic medical specialty. This device is an implant.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KYF
Device Class: FDA class 2
Regulation Number: 886.3920
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 25 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K231051	Ahmed® Glaucoma Valve Model FP8	May 12, 2023	Substantially Equivalent	New World Medical, Inc.
K230975	Ahmed® Glaucoma Valve Model FP7	May 12, 2023	Substantially Equivalent	New World Medical, Inc.
K220032	iStent infinite Trabecular Micro-Bypass System, Model iS3	Aug 02, 2022	Substantially Equivalent	Glaukos Corporation
K182518	AHMED ClearPath Glaucoma Drainage Device	Jan 18, 2019	Substantially Equivalent	New World Medical, Inc.
K171451	Ahmed Glaucoma Valve Model FP8	Aug 08, 2017	Substantially Equivalent	New World Medical, Inc.
K161457	XEN Glaucoma Treatment System	Nov 21, 2016	Substantially Equivalent	Allergan, Inc.
K162060	Ahmed Glaucoma Valve	Oct 24, 2016	Substantially Equivalent	New World Medical, Inc.
K152996	Molteno3 Glaucoma Implant	Dec 17, 2015	Substantially Equivalent	Innovative Ophthalmic Products, Inc. (Iop)
K062252	MOLTENO3	Sep 27, 2006	Substantially Equivalent	Iop, Inc.
K060644	AHMED GLAUCOMA VALVE, MODEL M4	Sep 18, 2006	Substantially Equivalent	New World Medical, Inc.
K030350	EXPRESS MINI GLAUCOMA SHUNT	Mar 13, 2003	Substantially Equivalent	Optonol, Ltd.
K012852	EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS	Mar 26, 2002	Substantially Equivalent	Optonol, Ltd.
K991072	AHMED GLAUCOMA VALVE IMPLANT	Jul 13, 1999	Substantially Equivalent	New World Medical, Inc.
K980657	AHMED GLAUCOMA VALVE, MODEL S3	Apr 20, 1998	Substantially Equivalent	New World Medical, Inc.
K955455	BAERVELT PARS PLANA GLAUCOMA IMPLANT	Feb 18, 1997	Substantially Equivalent	Pharmacia Iovision, Inc.
K925636	AHMED GLAUCOMA VALVE IMPLANT	Nov 12, 1993	Substantially Equivalent	New World Medical, Inc.
K905703	KRUPIN EYE VALVE WITH DISK	Mar 15, 1991	Substantially Equivalent	Hood Laboratories
K902296	TRABECULO-SUPRACHOROIDAL SHUNT	Mar 14, 1991	Substantially Equivalent	Visionex, Inc.
K905129	BAERVELDT GLAUCOMA IMPLANT	Feb 11, 1991	Substantially Equivalent	Wright Medical Corp.
K903462	OPTIMED GLAUCOMA PRESSURE REGULATOR	Oct 16, 1990	Substantially Equivalent	Optimed, Inc.
K902489	MODIFIED MOLTENO(TM) IMPLANTS	Aug 14, 1990	Substantially Equivalent	Iop, Inc.
K890598	MOLTENO IMPLANT	Feb 27, 1989	Substantially Equivalent	Iop, Inc.
K885125	KRUPIN EYE VALVE W/SCLERAL BUCKLE	Jan 24, 1989	Substantially Equivalent	Hood Laboratories
K875099	MOLTENO VALVE SETON	Mar 30, 1988	Substantially Equivalent	Staar Surgical Co.
K840204	WHITE OCULAR PRESSURE RELIEF DEVICE	Feb 15, 1985	Substantially Equivalent	Precision-Cosmet Co., Inc.