# K030350: Express Mini Glaucoma Shunt

- Pathway: 510(k) (Abbreviated)
- Applicant: Optonol, Ltd.
- Decided: Mar 13, 2003 after 38 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: 4 generations back to K875099 (1988). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012852: EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS Versions, Optonol, Ltd. (2002) Summary page 1.

## Indications for use
The EX-PRESSTMMiniature Glaucoma Family of Implants are intended to reduce intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed.

Source page: https://510kreport.com/device/K030350
Methodology: https://510kreport.com/methodology