# K041869: Self Retaining Bicanaliculus Intubation Set

- Pathway: 510(k) (Traditional)
- Applicant: Fci Ophthalmics, Inc.
- Decided: Nov 18, 2004 after 132 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K120886: Lacrifast (2012), 2 descendants of its own
- K130375: Self-Retaining Bicanaliculus Intubaton Set II (2013), 1 descendant of its own
- K170247: Lacriflow CL (2017), 0 descendants of its own
- K161373: Nunchaku (2016), 0 descendants of its own

## Indications for use
Bicanalicular intubation is indicated in treatments of epiphora in adults (not to be used in infants), particularly in cases of: - Meatic pathologies (meatic atresia) - Canalicular pathologies (canalicular stricture)

Source page: https://510kreport.com/device/K041869
Methodology: https://510kreport.com/methodology