# EAT: Tester, Pulp

- Device class: 2; regulation: 21 CFR 872.1720; FDA's rule: 510(k) exempt
- FDA decisions: 22
- 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)
- 1988: 1
- 1989: 1
- 1993: 1
- 1994: 1
- 1995: 2
- 1996: 2
- 1997: 2
- 1999: 1
- 2001: 2
- 2002: 2

## Most-cited predicates
- K970715: System B Heat Source (1997), cited by 1
- K963862: Touch N' Heat (1996), cited by 1
- K011666: Chillit (2001), cited by 1

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