# K980657: Ahmed Glaucoma Valve, Model S3

- Pathway: 510(k) (Traditional)
- Applicant: New World Medical, Inc.
- Decided: Apr 20, 1998 after 74 days
- Product code: KYF (Implant, Eye Valve)
- Device class: 2
- Regulation: 21 CFR 886.3920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K875099 (1988). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925636: Ahmed Glaucoma Valve Implant, New World Medical, Inc. (1993) Summary page 1.

## Most influential descendants
- K012852: EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS Versions (2002), 3 descendants of its own
- K171451: Ahmed Glaucoma Valve Model FP8 (2017), 1 descendant of its own
- K161457: XEN Glaucoma Treatment System (2016), 1 descendant of its own
- K231051: Ahmed® Glaucoma Valve Model FP8 (2023), 0 descendants of its own
- K220032: iStent infinite Trabecular Micro-Bypass System, Model iS3 (2022), 0 descendants of its own

## Indications for use
The Ahmed Glaucoma Valve is indicated for the management of refractory glaucomas, where previous surgical treatment has failed, or by experience is known not to provide satisfactory results. Such refractory glaucomas can include neovascular glaucoma, primary open angle glaucoma unresponsive to medication, congenital or infantile glaucoma, and refractory glaucomas resulting from aphakia or uveitis.

Source page: https://510kreport.com/device/K980657
Methodology: https://510kreport.com/methodology