# GJT: Plasma, Coagulation Factor Deficient

- Device class: 2; regulation: 21 CFR 864.7290; FDA's rule: 510(k) required
- FDA decisions: 79
- 510(k) review time 2021–2025: median 359 days (middle half 359–359)
- 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)
- 1996: 2
- 1997: 9
- 1998: 1
- 1999: 5
- 2003: 5
- 2004: 2
- 2005: 2
- 2011: 3
- 2018: 1
- 2023: 1

## Most-cited predicates
- K893525: Factor Viii Deficient Plasma (1989), cited by 3
- K893535: Factor Vii Deficient Plasma (1989), cited by 2
- K893536: Factor XI Deficient Plasma (1989), cited by 2
- K893523: Factor X Deficient Plasma (1989), cited by 2
- K900133: Factor II Deficient Plasma (1990), cited by 2
- K031829: Hemosil Factor IX Deficient Plasma (2003), cited by 2
- K893533: Factor V Deficient Plasma (1989), cited by 2
- K893524: Factor IX Deficient Plasma (1989), cited by 2
- K893534: Factor Xii Deficient Plasma (1989), cited by 2
- K043459: Hemosil Factor Xii Deficient Plasma (2005), cited by 1

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