# KRG: Programmer, Pacemaker

- Device class: 3; regulation: 21 CFR 870.3700; FDA's rule: PMA required
- FDA decisions: 25
- Recalls: 9 (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)
- 1999: 7
- 2000: 13
- 2001: 7
- 2002: 2
- 2003: 9
- 2004: 2
- 2005: 2
- 2013: 1
- 2014: 1
- 2015: 2

## Most-cited predicates

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