# K113867: Lacricath Lacrimal Duct Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Quest Medical, Inc.
- Decided: Oct 19, 2012 after 294 days
- Product code: OKS (Lacrimal Stents And Intubation Sets)
- 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 K935233 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935233: Iolab Lacrimal Duct Catheter, Chiron Vision Corp. (1994) Summary page 1.

## Most influential descendants
- K123831: Ophtacath Kit (2013), 0 descendants of its own

## Indications for use
The LacriCATH Lacrimal Duct Balloon Catheter is a sterile, prescription device indicated for single-use during dilatation of an obstructed nasolacrimal duct to correct epiphora as a result of the following: 5mm LacriCATH Adult catheter: functional or complete nasolacrimal duct obstruction dacryocystitis failed DCR (dacryocystorhinostomy) 2mm/3mm LacriCATH Pediatric catheter (intended for patients 12 months of age and older): congenital nasolacrimal duct obstruction dacryocystocele

Source page: https://510kreport.com/device/K113867
Methodology: https://510kreport.com/methodology
