# KAM: Cannula, Sinus

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 19
- 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)
- 1995: 3
- 1997: 1
- 2000: 1
- 2005: 1
- 2006: 2
- 2007: 1
- 2008: 2
- 2009: 1
- 2010: 1
- 2011: 1

## Most-cited predicates
- K073041: Relieva and Relieva Acella Sinus Balloon Catheter (2008), cited by 4
- K071845: Relieva Luma Sinus Illumination System, Model Sis-100A (2007), cited by 4
- K062458: Ethmoid Sinus Spacer (2006), cited by 1
- K072891: Sinus Spacer (2008), cited by 1
- K083574: Relieva Stratus Microflow Spacer (2009), cited by 1
- K050340: Micromedics Sphenoid Sinus Stent (2005), cited by 1
- K951066: Rains Frontal Sinus Stent (1995), cited by 1
- K912418: Shikani Middle Meatal Antrostomy Vent Tube (1991), cited by 1
- K093594: Modification to Relieva Stratus Microflow Spacer (2010), cited by 1

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