# K061404: Mono-Crawford Naso-Lacrimal Intubation Device

- Pathway: 510(k) (Traditional)
- Applicant: Fci Ophthalmics, Inc.
- Decided: Aug 7, 2006 after 80 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.
7 later devices descend from it; 3 cite it directly.
0 of 8 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
- K121142: Crawford Biocanaliculus Intubation (2012), 2 descendants of its own
- K113316: DCS Lacrimal Stent (2012), 1 descendant of its own
- K113536: Masterka 40 Masterka 35 Masterka 30 (2012), 1 descendant of its own
- K201606: LacriJet® (2020), 0 descendants of its own
- K161373: Nunchaku (2016), 0 descendants of its own

## Indications for use
Indicated in initial surgery in the treatment of monocanalicular lacerations and stenoses requiring intubation. Further indications are: Congenital lacrimal duct obstructions Canalicular lacerations After treatment of canaliculitis with concretions when curettage of a canaliculus has been performed. After cacryocystorhinostomy Epiphora

Source page: https://510kreport.com/device/K061404
Methodology: https://510kreport.com/methodology