FDA Product Code KYF: Implant, Eye Valve
Leading manufacturers include New World Medical, Inc., Allergan, Inc. and Glaukos Corporation.
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
Cleared
May 12, 2023
Ahmed® Glaucoma Valve Model FP7
New World Medical, Inc.
Ophthalmic
37d
Cleared
May 12, 2023
Ahmed® Glaucoma Valve Model FP8
New World Medical, Inc.
Ophthalmic
29d
Cleared
Aug 02, 2022
iStent infinite Trabecular Micro-Bypass System, Model iS3
Glaukos Corporation
Ophthalmic
209d
Cleared
Jan 18, 2019
AHMED ClearPath Glaucoma Drainage Device
New World Medical, Inc.
Ophthalmic
127d
Cleared
Nov 21, 2016
XEN Glaucoma Treatment System
Allergan, Inc.
Ophthalmic
179d
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.