# BSS: Tube, Nasogastric

- Device class: 2; regulation: 21 CFR 876.5980; FDA's rule: 510(k) required
- FDA decisions: 13
- Recalls: 5 (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)
- 1979: 1
- 1989: 2
- 1991: 2
- 1994: 2
- 1995: 2
- 1997: 1
- 1999: 1
- 2005: 1
- 2014: 1

## Most-cited predicates
- K984629: Moss Tubes, Inc. Nasal Tube - Mark IV (1999), cited by 2
- K935688: AN-10S Andersen Tube with Stylet (1994), cited by 2

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