# K925636: Ahmed Glaucoma Valve Implant

- Pathway: 510(k) (Traditional)
- Applicant: New World Medical, Inc.
- Decided: Nov 12, 1993 after 368 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: 1 generation back to K875099 (1988). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K875099: Molteno Valve Seton, Staar Surgical Co. (1988) Summary page 1.

## Most influential descendants
- K980657: Ahmed Glaucoma Valve, Model S3 (1998), 6 descendants of its own
- K162060: Ahmed Glaucoma Valve (2016), 3 descendants of its own
- 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

## Indications for use
The Ahmed Glaucoma Valve is indicated for the management of refractory glaucoma where previous surgical treatment has failed, or experience is known to provide unsatisfactory results. Refractory glaucoma can include primary open angle glaucoma unresponsive to medication, primary neovascular glaucoma and other types of glaucoma.

Source page: https://510kreport.com/device/K925636
Methodology: https://510kreport.com/methodology