# OKS: Lacrimal Stents And Intubation Sets

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 31
- 510(k) review time 2021–2025: median 246 days (middle half 246–246)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2004: 1
- 2006: 1
- 2012: 7
- 2013: 2
- 2014: 1
- 2015: 1
- 2016: 2
- 2017: 1
- 2020: 1
- 2021: 1

## Most-cited predicates
- K061404: Mono-Crawford Naso-Lacrimal Intubation Device (2006), cited by 3
- K962151: Ryder Lacrimal Intubationset (1996), cited by 2
- K041869: Self Retaining Bicanaliculus Intubation Set (2004), cited by 2
- K935233: Iolab Lacrimal Duct Catheter (1994), cited by 2
- K121142: Crawford Biocanaliculus Intubation (2012), cited by 2
- K120886: Lacrifast (2012), cited by 2
- K883233: EV Monocanalicular Stent (TM) (1988), cited by 2
- K955671: Ritleng Bican.Lacr.Sets/Self Thread. Monokas (CHG.in Ster.) (1996), cited by 2
- K991238: Fci Crawford Probe Intubation Sets (1999), cited by 2
- K113536: Masterka 40 Masterka 35 Masterka 30 (2012), cited by 1

Source page: https://510kreport.com/product-code/OKS
Data by year (CSV): https://510kreport.com/product-code/OKS.csv