# JMO: Ferrozine (Colorimetric) Iron Binding Capacity

- Device class: 1; regulation: 21 CFR 862.1415; FDA's rule: 510(k) exempt
- FDA decisions: 46
- Recalls: 3 (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)
- 1995: 1
- 1996: 4
- 1998: 4
- 1999: 3
- 2000: 2
- 2001: 2
- 2004: 1
- 2005: 1
- 2006: 1
- 2012: 1

## Most-cited predicates
- K994115: Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge (2000), cited by 2
- K000781: Direct Tibc Kit (2000), cited by 1
- K893662: J&S Iron Saturating Reagents (1989), cited by 1
- K770748: Test, Ferrozine Iron & Iron Binding (1977), cited by 1
- K931493: Kodak Ektachem Total Iron-Binding Capacity Kit (1993), cited by 1
- K113438: Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase Reagent (2012), cited by 1

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