# KHO: Fluorometer, For Clinical Use

- Device class: 1; regulation: 21 CFR 862.2560; FDA's rule: 510(k) exempt
- FDA decisions: 38
- Recalls: 17 (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)
- 1990: 1
- 1991: 1
- 1992: 2
- 1993: 2
- 1994: 1
- 1995: 2
- 1996: 1
- 1997: 1
- 1998: 1
- 2012: 1

## Most-cited predicates
- K973547: Triage Statmeter (1998), cited by 4
- K935047: Auto Delfia (1994), cited by 2
- K962919: Vitros Immunodiagnostic System (1996), cited by 1
- K112161: AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS 1-3, AQT90 Flex Myo Cal Cartridge.. (2012), cited by 1

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