# JQX: Nephelometer, For Clinical Use

- Device class: 1; regulation: 21 CFR 862.2700; FDA's rule: 510(k) exempt
- FDA decisions: 14
- Recalls: 4 (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)
- 1977: 1
- 1978: 4
- 1979: 2
- 1980: 2
- 1985: 2
- 1989: 1
- 1992: 1
- 1996: 1

## Most-cited predicates
- K922273: Array (R) 360 (1992), cited by 8

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