KYFClass II

Implant, Eye Valve

21 CFR 886.3920 / Ophthalmic

KYF is the FDA product code for Implant, Eye Valve, a class II device type, regulated under 21 CFR 886.3920. As of 2026-09-10, FDA records hold 25 510(k) clearances under this code, the most recent dated 2023-05-12, and 6 recalls.

Classification record

Product code: KYF
Device name: Implant, Eye Valve
Regulation: 21 CFR 886.3920
Device class: Class II
Review panel: Ophthalmic
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 25
Ingested recalls: 6

Clearances, product code KYF

By decision year

25 clearances under product code KYF with a decision year between 1985 and 2023, 1991 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code KYF by decision year
Year	Clearances
1985	1
1988	1
1989	2
1990	2
1991	3
1993	1
1997	1
1998	1
1999	1
2002	1
2003	1
2006	2
2015	1
2016	2
2017	1
2019	1
2022	1
2023	2

Applicants with the most clearances

Product code KYF

Applicants holding the most 510(k) clearances under product code KYF
Applicant	Clearances
New World Medical, Inc.	9
Hood Laboratories	2
Iop, Inc.	2
Optonol, Ltd	2
Allergan	1
Glaukos Corporation	1
Innovative Ophthalmic Products, Inc. (Iop)	1
Iop, Inc.	1
Optimed, Inc.	1
Pharmacia Iovision, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order