# OTK: Wound Drain Catheter System

- Device class: 2; regulation: 21 CFR 878.4780; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 104 days (middle half 104–104)
- 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)
- 2010: 1
- 2015: 1
- 2016: 2
- 2018: 1
- 2019: 1
- 2021: 1

## Most-cited predicates
- K163139: PleuraFlow System with FlowGlide (2016), cited by 2
- K150042: PleuraFlow System (2015), cited by 2
- K093565: Pleuraflow Catheter System (2010), cited by 1

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