# K905703: Krupin Eye Valve with Disk

- Pathway: 510(k) (Traditional)
- Applicant: Hood Laboratories
- Decided: Mar 15, 1991 after 85 days
- Product code: KYF (Implant, Eye Valve)
- Device class: 2
- Regulation: 21 CFR 886.3920
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Apr 12, 2006 · Not classified · Z-0845-06: Product may have deformed valves which would cause the valve not to operate properly.
- Apr 12, 2006 · Not classified · Z-0846-06: Product may have deformed valves which would cause the valve not to operate properly.
- Apr 12, 2006 · Not classified · Z-0844-06: Product may have deformed valves which would cause the valve not to operate properly.
- Apr 12, 2006 · Not classified · Z-0847-06: Product may have deformed valves which would cause the valve not to operate properly.

Source page: https://510kreport.com/device/K905703
Methodology: https://510kreport.com/methodology