# JIN: Nitroprusside, Ketones (Urinary, Non-Quant.)

- Device class: 1; regulation: 21 CFR 862.1435; FDA's rule: 510(k) exempt
- FDA decisions: 24
- Recalls: 5 (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)
- 1988: 1
- 1990: 3
- 1991: 3
- 1996: 2
- 2001: 1
- 2004: 1
- 2006: 1
- 2017: 1
- 2018: 3
- 2020: 2

## Most-cited predicates
- K911801: Ketosite (TM)/Stat-Site (TM)/Ketosite (TM) Low-HI Con (1991), cited by 1
- K170463: KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System (2018), cited by 1
- K801270: Test for Ketone in Urine (Acetoacetic AC (1980), cited by 1
- K850368: Sigms B-Hydroxybutarate Procedure NO. 310-UV (1985), cited by 1

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