FDA Product Code KYF: Implant, Eye Valve
Leading manufacturers include New World Medical, Inc. and Glaukos Corporation.
25
Total
25
Cleared
141d
Avg days
1985
Since
Declining activity -
0 submissions in the last 2 years
vs 3 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
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 3 in the prior period.
KYF devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →