# CFM: Bathophenanthroline, Colorimetry, Iron (Non-Heme)

- Device class: 1; regulation: 21 CFR 862.1410; FDA's rule: 510(k) exempt
- FDA decisions: 21
- 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)
- 1984: 5
- 1985: 2
- 1986: 1
- 1987: 1
- 1989: 2
- 1990: 1
- 1991: 2
- 1993: 1
- 1998: 1
- 1999: 1

## Most-cited predicates

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