# K090938: Flow Controller

- Pathway: 510(k) (Traditional)
- Applicant: Odyssey Medical, Inc.
- Decided: Jun 4, 2009 after 62 days
- Product code: LZU (Plug, Punctum)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970631 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970631: Punctual Occluder, Odyssey Medical, Inc. (1997) Summary page 1.

## Indications for use
Punctal Occluders (plugs) are indicated for the treatment of "dry eye" syndrome.

Source page: https://510kreport.com/device/K090938
Methodology: https://510kreport.com/methodology