# JQP: Calculator/Data Processing Module, For Clinical Use

- Device class: 1; regulation: 21 CFR 862.2100; FDA's rule: 510(k) exempt
- FDA decisions: 78
- Recalls: 153 (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)
- 1986: 5
- 1987: 3
- 1988: 1
- 1989: 3
- 1993: 1
- 1994: 1
- 1995: 1
- 1997: 1
- 1998: 1
- 2012: 1

## Most-cited predicates
- K861844: Glucofacts Data Management System (1986), cited by 1
- K113007: Bionime Diabetes Management System VI.0 (2012), cited by 1

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