KYF · Class II · 21 CFR 886.3920

FDA Product Code KYF: Implant, Eye Valve

Leading manufacturers include New World Medical, Inc., Hood Laboratories and Optonol, Ltd..

25
Total
25
Cleared
141d
Avg days
1985
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Implant, Eye Valve Devices (Product Code KYF)

25 devices
1–24 of 25
Cleared May 12, 2023
Ahmed® Glaucoma Valve Model FP7
K230975
New World Medical, Inc.
Ophthalmic · 37d
Cleared May 12, 2023
Ahmed® Glaucoma Valve Model FP8
K231051
New World Medical, Inc.
Ophthalmic · 29d
Cleared Aug 02, 2022
iStent infinite Trabecular Micro-Bypass System, Model iS3
K220032
Glaukos Corporation
Ophthalmic · 209d
Cleared Jan 18, 2019
AHMED ClearPath Glaucoma Drainage Device
K182518
New World Medical, Inc.
Ophthalmic · 127d
Cleared Aug 08, 2017
Ahmed Glaucoma Valve Model FP8
K171451
New World Medical, Inc.
Ophthalmic · 83d
Cleared Nov 21, 2016
XEN Glaucoma Treatment System
K161457
Allergan, Inc.
Ophthalmic · 179d
Cleared Oct 24, 2016
Ahmed Glaucoma Valve
K162060
New World Medical, Inc.
Ophthalmic · 90d
Cleared Dec 17, 2015
Molteno3 Glaucoma Implant
K152996
Innovative Ophthalmic Products, Inc. (Iop)
Ophthalmic · 65d
Cleared Sep 27, 2006
MOLTENO3
K062252
Iop, Inc.
Ophthalmic · 55d
Cleared Sep 18, 2006
AHMED GLAUCOMA VALVE, MODEL M4
K060644
New World Medical, Inc.
Ophthalmic · 192d
Cleared Mar 26, 2002
EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS
K012852
Optonol, Ltd.
Ophthalmic · 214d
Cleared Jul 13, 1999
AHMED GLAUCOMA VALVE IMPLANT
K991072
New World Medical, Inc.
Ophthalmic · 104d
Cleared Apr 20, 1998
AHMED GLAUCOMA VALVE, MODEL S3
K980657
New World Medical, Inc.
Ophthalmic · 74d
Cleared Feb 18, 1997
BAERVELT PARS PLANA GLAUCOMA IMPLANT
K955455
Pharmacia Iovision, Inc.
Ophthalmic · 447d
Cleared Mar 15, 1991
KRUPIN EYE VALVE WITH DISK
K905703
Hood Laboratories
Ophthalmic · 85d
Cleared Jan 24, 1989
KRUPIN EYE VALVE W/SCLERAL BUCKLE
K885125
Hood Laboratories
Ophthalmic · 43d
Cleared Mar 30, 1988
MOLTENO VALVE SETON
K875099
Staar Surgical Co.
Ophthalmic · 111d

About Product Code KYF - Regulatory Context

510(k) Submission Activity

25 total 510(k) submissions under product code KYF since 1985, with 25 receiving FDA clearance (average review time: 141 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.