# K060644: Ahmed Glaucoma Valve, Model M4

- Pathway: 510(k) (Traditional)
- Applicant: New World Medical, Inc.
- Decided: Sep 18, 2006 after 192 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ahmed Glaucoma Valve Model S2: named in the summary without a submission number
- (no number) Ahmed Glaucoma Valve Model S3: named in the summary without a submission number

## Indications for use
The AhmedTM 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/K060644
Methodology: https://510kreport.com/methodology