# JHW: U.V. Method, Cpk Isoenzymes

- Device class: 2; regulation: 21 CFR 862.1215; FDA's rule: 510(k) required
- FDA decisions: 27
- 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)
- 1991: 3
- 1993: 1
- 1994: 2
- 1995: 2
- 1996: 1
- 2000: 1
- 2003: 1
- 2012: 1
- 2014: 1
- 2017: 1

## Most-cited predicates
- K003158: Roche Diagnostics CK-MB (2000), cited by 6
- K961501: Elecsys CK-MB (1996), cited by 2
- K122083: Elitech Clinical Systems CK Nac SL (2012), cited by 1
- K935924: Axsym CK-MB (1994), cited by 1

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