# NPF: Monitor, Apnea, Home Use

- Device class: 2; regulation: 21 CFR 868.2377; FDA's rule: 510(k) required
- FDA decisions: 2
- Recalls: 2 (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)
- 2003: 1
- 2006: 1

## Most-cited predicates
- K032403: Smartmonitor 2 Professional Series (PS) (2003), cited by 1

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