# K161457: XEN Glaucoma Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Allergan, Inc.
- Decided: Nov 21, 2016 after 179 days
- Product code: KYF (Implant, Eye Valve)
- Device class: 2
- Regulation: 21 CFR 886.3920
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K875099 (1988). 7 ancestors in all.
1 later device descends from it; 1 cites 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 4.
- K012852: EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS Versions, Optonol, Ltd. (2002) Summary page 4.

## Most influential descendants
- K220032: iStent infinite Trabecular Micro-Bypass System, Model iS3 (2022), 0 descendants of its own

## Recalls of this device
- Oct 30, 2019 · Class II · Z-0598-2020: Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds could transfer to the patient's eye duri

## Indications for use
The XEN Glaucoma Treatment System is indicated for the management of refractory glaucomas, including cases where previous surgical treatment has failed, cases of primary open angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.

Source page: https://510kreport.com/device/K161457
Methodology: https://510kreport.com/methodology