# K220032: iStent infinite Trabecular Micro-Bypass System, Model iS3

- Pathway: 510(k) (Traditional)
- Applicant: Glaukos Corporation
- Decided: Aug 2, 2022 after 209 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: 5 generations back to K875099 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161457: XEN Glaucoma Treatment System, Allergan, Inc. (2016) Summary page 4.

## Indications for use
The iStent infinite® Trabecular Micro-Bypass System Model iS3 an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed.

Source page: https://510kreport.com/device/K220032
Methodology: https://510kreport.com/methodology