# KZM: Device, Muscle Monitoring

- Device class: 2; regulation: 21 CFR 890.1375; FDA's rule: 510(k) required
- FDA decisions: 19
- 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)
- 1998: 1
- 1999: 1
- 2000: 1
- 2001: 1
- 2004: 1
- 2005: 1
- 2009: 1
- 2012: 1
- 2013: 1
- 2016: 1

## Most-cited predicates
- K030869: Bitestrip (2004), cited by 2
- K082927: Bioemg Iii (2009), cited by 1
- K992694: Modification to K6-I Diagnostic System, Model K6-I (1999), cited by 1
- K003176: Bioemg II and Biojva (2001), cited by 1

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