# KMI: Monitor, Bed Patient

- Device class: 1; regulation: 21 CFR 880.2400; FDA's rule: 510(k) exempt
- FDA decisions: 31
- Recalls: 22 (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
- 1990: 2
- 1991: 3
- 1992: 2
- 1993: 2
- 1994: 5
- 2009: 1
- 2010: 1
- 2013: 2
- 2014: 1

## Most-cited predicates
- K090138: Mobilecare Monitor, Model 2100 (2009), cited by 4
- K101109: Vivatrak (2010), cited by 3
- K141877: Leaf Patient Monitoring System (2014), cited by 2
- K130752: Dynasense System (2013), cited by 1
- K925529: Wander Care (1993), cited by 1

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