# JIO: Blood, Occult, Colorimetric, In Urine

- Device class: 2; regulation: 21 CFR 864.6550; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 267 days (middle half 267–267)
- Recalls: 0 (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)
- 1989: 1
- 1991: 2
- 1992: 1
- 2003: 1
- 2004: 1
- 2009: 2
- 2012: 2
- 2024: 1

## Most-cited predicates
- K905396: Hemastix Reagent Strips (1991), cited by 4
- K040703: Uristik H Series Reagent Strips for Urinalysis (2004), cited by 2
- K082811: Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine Analyzers (2009), cited by 1
- K111221: Mission U500 Urine Analyzer (2012), cited by 1

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