# CEF: Electrophoretic, Protein Fractionation

- Device class: 1; regulation: 21 CFR 862.1630; FDA's rule: 510(k) exempt
- FDA decisions: 29
- 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)
- 1987: 1
- 1989: 2
- 1990: 1
- 1991: 4
- 1992: 3
- 1993: 1
- 1995: 1
- 1996: 2
- 1997: 3
- 2013: 1

## Most-cited predicates
- K130500: Capillarys Immunotyping, Capillarys 2 Instrument, IT/IF Control, Capillarys 2 Flex Piercing Instrument (2013), cited by 2
- K802592: Paragon Serum Protein Electrophoresis (1980), cited by 2

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