# K230975: Ahmed® Glaucoma Valve Model FP7

- Pathway: 510(k) (Special)
- Applicant: New World Medical, Inc.
- Decided: May 12, 2023 after 37 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: 3 generations back to K875099 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162060: Ahmed Glaucoma Valve, New World Medical, Inc. (2016) Summary page 5.

## Indications for use
The Ahmed® Glaucoma Valve Model FP7 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 medications, congenital or infantile glaucoma and refractory glaucomas resulting from aphakia or uveitis.

Source page: https://510kreport.com/device/K230975
Methodology: https://510kreport.com/methodology