# JOX: Analyzer, Heparin, Automated

- Device class: 2; regulation: 21 CFR 864.5680; FDA's rule: 510(k) required
- FDA decisions: 15
- 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)
- 1984: 1
- 1985: 1
- 1989: 1
- 1991: 1
- 1992: 1
- 2000: 1
- 2004: 2
- 2005: 1
- 2010: 2
- 2011: 1

## Most-cited predicates
- K894317: Hemotec Hepcon HMS Coagulation System &  Access. (1989), cited by 5
- K042070: Heparin Dose Response Cartridge, Model 304-20 (2004), cited by 1
- K911240: Hepcon HMS with Body Surface Area Calculation (1991), cited by 1
- K043080: Heparin Dose Response Controls, Model 306-20 Por (2004), cited by 1
- K101271: Hemostasis Management System Plus (HMS Plus ), Model 305 XX (2010), cited by 1
- K922031: HMS Purple and Black Heparin Cartridges & Control (1992), cited by 1

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