# K022043: Smart Plug, Model 500; Smartplug Forceps, Model 502; Push Rod, Model 503

- Pathway: 510(k) (Traditional)
- Applicant: Medennium, Inc.
- Decided: Oct 18, 2002 after 116 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
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040912: Hydrogel Canalicular Plug (2004), 1 descendant of its own
- K222164: Visant Medical Canalicular Plug (2022), 0 descendants of its own
- K053333: Eaglevision Gellanserts, Model Ref 0040 (2006), 0 descendants of its own

## Indications for use
SmartPlugTM 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. SmartPlugTM may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases. When indicated, SmartPlugTM 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 SmartPlugTM.

Source page: https://510kreport.com/device/K022043
Methodology: https://510kreport.com/methodology