# K012852: EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS Versions

- Pathway: 510(k) (Traditional)
- Applicant: Optonol, Ltd.
- Decided: Mar 26, 2002 after 214 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: 3 generations back to K875099 (1988). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980657: Ahmed Glaucoma Valve, Model S3, New World Medical, Inc. (1998) Summary page 1.
- K903462: Optimed Glaucoma Pressure Regulator, Optimed, Inc. (1990) Summary page 1.
- K905129: Baerveldt Glaucoma Implant, Wright Medical Corp. (1991) Summary page 1.
- K955455: Baervelt Pars Plana Glaucoma Implant, Pharmacia Iovision, Inc. (1997) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The Ex-PRESS™ Miniature Glaucoma Implant is intended to reduce intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed.

Source page: https://510kreport.com/device/K012852
Methodology: https://510kreport.com/methodology