# K123831: Ophtacath Kit

- Pathway: 510(k) (Traditional)
- Applicant: France Chirurgae Instrumentation
- Decided: Jul 29, 2013 after 229 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: 5 generations back to K854261 (1985). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113867: Lacricath Lacrimal Duct Catheter, Quest Medical, Inc. (2012)
- K082755: Sedat Flamingo, Sedat (2008) Summary page 1.
- K972964: Atrion Medical Balloon Catheter Inflation Device, Atrion Medical Products, Inc. (1997) Summary page 2.

## Indications for use
The OphtaCath®D Unilateral Kits (2-mm and 3-mm) are intended for use during dilation of the obstructed nasolacrimal duct to treat epiphora. For patients older than 12 months but under 30 months, the recommended catheter is the 2 mm balloon diameter. For patients 30 months and older, the recommended catheter is the 3 mm balloon diameter.

Source page: https://510kreport.com/device/K123831
Methodology: https://510kreport.com/methodology