# FLS: Monitor, Apnea, Facility Use

- Device class: 2; regulation: 21 CFR 868.2377; FDA's rule: 510(k) required
- FDA decisions: 16
- 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)
- 1978: 1
- 1980: 2
- 1981: 1
- 1982: 3
- 1983: 1
- 1984: 1
- 1989: 1
- 1996: 2
- 2000: 1
- 2002: 1

## Most-cited predicates
- K951246: Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography Options (1996), cited by 5
- K962865: Rembrandt System (1996), cited by 3
- K011597: Smartmonitor 2, Model 4000 (2002), cited by 1
- K822077: Respiration Monitor Type MR-10 (1982), cited by 1

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