# GFO: Activated Partial Thromboplastin

- Device class: 2; regulation: 21 CFR 864.7925; FDA's rule: 510(k) required
- FDA decisions: 52
- Recalls: 6 (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: 2
- 1997: 3
- 1999: 2
- 2002: 3
- 2005: 1
- 2006: 2
- 2016: 1
- 2020: 1
- 2026: 1

## Most-cited predicates
- K891337: Thromboscreen Aptt Reagent (1989), cited by 2
- K972831: Hemochron Citrate Aptt (1997), cited by 1
- K890052: Biotrack Aptt Reagent Cartridge (1989), cited by 1
- K760318: Actin, Activated Cephaloplastin Reagent (1976), cited by 1
- K953981: Synthasil Aptt Reagent (1995), cited by 1
- K050221: Hemosil Silica Clotting Time (2005), cited by 1
- K160445: HemosIL Silica Clotting Time (2016), cited by 1
- K923731: Staclot LA Test Kit (1992), cited by 1

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