# BSB: Warmer, Blood, Non-Electromagnetic Radiation

- Device class: 2; regulation: 21 CFR 864.9205; FDA's rule: 510(k) required
- FDA decisions: 14
- Recalls: 1 (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)
- 1996: 1
- 1998: 1
- 1999: 3
- 2001: 1
- 2002: 1
- 2003: 1
- 2005: 1
- 2006: 1
- 2009: 1
- 2011: 1

## Most-cited predicates
- K973741: Bair Hugger Blood/Fluid Warmer (1998), cited by 7
- K770232: Blood/Fluid Warmer Model DW-1000A (1977), cited by 3
- K012031: Modification to Thermal Angel (2001), cited by 2
- K984640: Thermal Angel (1999), cited by 2
- K020060: Astoflo (2002), cited by 1

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