# K113508: Dacryocath

- Pathway: 510(k) (Traditional)
- Applicant: Armadillo Biomedical, LLC
- Decided: Aug 31, 2012 after 277 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
- K142914: DacryoCATH (2015), 0 descendants of its own

## Indications for use
The lacrimal duct catheter is indicated for use during dilation of the obstructed nasolacrimal duct in the following populations: b. The 2mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct obstruction in patients over 12 months of age and under 30 months of age. b. The 3 mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct in children over 30 months of age. c. The 5mm catheter is indicated for use in adults during dilation of a lacrimal duct obstruction or blocked dacryocystorhinostomy ostium as a result of the following: functional or complete nasolacrimal duct obstruction, dacryocystitis, or failed dacryocystorhinostomy.

Source page: https://510kreport.com/device/K113508
Methodology: https://510kreport.com/methodology