# K182518: AHMED ClearPath Glaucoma Drainage Device

- Pathway: 510(k) (Traditional)
- Applicant: New World Medical, Inc.
- Decided: Jan 18, 2019 after 127 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 K905129 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905129: Baerveldt Glaucoma Implant, Wright Medical Corp. (1991) Summary page 4.
- K955455: Baervelt Pars Plana Glaucoma Implant, Pharmacia Iovision, Inc. (1997) Summary page 4.

## Indications for use
The AHMED® ClearPath glaucoma drainage device is indicated for the management of refractory glaucoma where previous surgical treatment has failed or is not expected to provide satisfactory results. Such refractory glaucoma may include but is not limited to: neovascular glaucoma, congenital or infantile glaucoma, and refractory glaucoma resulting from aphakia or uveitis.

Source page: https://510kreport.com/device/K182518
Methodology: https://510kreport.com/methodology