# K903462: Optimed Glaucoma Pressure Regulator

- Pathway: 510(k) (Traditional)
- Applicant: Optimed, Inc.
- Decided: Oct 16, 1990 after 76 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012852: EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS Versions (2002), 3 descendants of its own
- K161457: XEN Glaucoma Treatment System (2016), 1 descendant of its own
- K220032: iStent infinite Trabecular Micro-Bypass System, Model iS3 (2022), 0 descendants of its own
- K030350: Express Mini Glaucoma Shunt (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K903462
Methodology: https://510kreport.com/methodology