# KTN: System, Test, Infectious Mononucleosis

- Device class: 2; regulation: 21 CFR 866.5640; FDA's rule: 510(k) required
- FDA decisions: 59
- Recalls: 1 (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)
- 1992: 6
- 1993: 4
- 1996: 1
- 1997: 4
- 1998: 1
- 1999: 1
- 2001: 1
- 2003: 1
- 2005: 1
- 2018: 1

## Most-cited predicates
- K972231: Osom Mono Test 143 (1997), cited by 2
- K862008: Mono-Latex (TM) Slide Test (1986), cited by 1
- K861016: Gamma Slide Test for Infectious Mononucleosis (1986), cited by 1

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