# K040912: Hydrogel Canalicular Plug

- Pathway: 510(k) (Traditional)
- Applicant: Partners IN Biomaterials, Inc.
- Decided: Nov 16, 2004 after 222 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 K946357 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022043: Smart Plug, Model 500; Smartplug Forceps, Model 502; Push Rod, Model 503, Medennium, Inc. (2002) Summary page 4.
- K946357: Collagen Intracanalicular Plug, Oasis Medical, Inc. (1995) Summary page 4.

## Most influential descendants
- K222164: Visant Medical Canalicular Plug (2022), 0 descendants of its own

## Indications for use
The Hydrogel Canalicular Plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching, or foreign body sensations, which can be relieved by blocking of the punctum. The Hydrogel Canalicular Plug may be used in the treatment of dry eye syndrome and the dry eye component of various ocular surface diseases. When indicated, the Hydrogel Canalicular Plug may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing dry eye related contact lens problems may also be aided by the Hydrogel Canalicular Plug.

Source page: https://510kreport.com/device/K040912
Methodology: https://510kreport.com/methodology