# KQO: Automated Urinalysis System

- Device class: 1; regulation: 21 CFR 862.2900; FDA's rule: 510(k) exempt
- FDA decisions: 46
- Recalls: 18 (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)
- 2003: 2
- 2005: 2
- 2006: 1
- 2007: 1
- 2009: 1
- 2010: 2
- 2011: 2
- 2013: 1
- 2014: 1
- 2015: 2

## Most-cited predicates
- K960546: Clinitek 50 Urine Chemistry Analyzer (1996), cited by 6
- K093098: Aution Max Model AX-4030 Urinalysis System (2009), cited by 4
- K031947: Bayer Clinitek Status Analyzer (2003), cited by 4
- K013783: Aution Max AX-4280 Urinalysis System (2002), cited by 4
- K926359: Clinitek 200+ Urine Chemistry Analyzer (1993), cited by 3
- K983510: Chemstrip 101 Urine Analyzer (1998), cited by 3
- K934042: Chemstrip Super UA Urine Analyzer (1993), cited by 2
- K946183: Clinitek Atlas Automated Urine Chemistry Analyzer (1995), cited by 2
- K030600: Aution Jet AJ-4270 Urine Analyzer (2003), cited by 2
- K101852: Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit (2011), cited by 2

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