# K142914: DacryoCATH

- Pathway: 510(k) (Special)
- Applicant: Armadillo Biomedical, LLC
- Decided: Jan 12, 2015 after 97 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: 2 generations back to K935233 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113508: Dacryocath, Armadillo Biomedical, LLC (2012) Summary page 4.

## Indications for use
The lacrimal duct catheter is indicated for use during dilation of the obstructed nasolacrimal duct in the following populations: a. 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/K142914
Methodology: https://510kreport.com/methodology