# KRE: Analyzer, Pacemaker Generator Function, Indirect

- Device class: 2; regulation: 21 CFR 870.3640; FDA's rule: 510(k) required
- FDA decisions: 13
- 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)
- 1980: 3
- 1981: 1
- 1983: 2
- 1987: 1
- 1990: 1
- 1992: 1
- 1993: 1
- 2003: 1
- 2008: 1
- 2011: 1

## Most-cited predicates
- K915632: Paceart CPTS-86/12 (1992), cited by 4
- K110693: Paceart Optima System Software (2011), cited by 1

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