# JFT: Fluorometric, Cortisol

- Device class: 2; regulation: 21 CFR 862.1205; FDA's rule: 510(k) required
- FDA decisions: 20
- 510(k) review time 2021–2025: median 329 days (middle half 329–329)
- Recalls: 2 (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)
- 1994: 1
- 1995: 1
- 1996: 1
- 2002: 1
- 2004: 1
- 2006: 1
- 2015: 1
- 2016: 1
- 2019: 1
- 2025: 1

## Most-cited predicates
- K962559: Acs Cortisol Immunoassay (1996), cited by 2
- K033731: Axsym Cortisol Assay (2004), cited by 1
- K152227: Elecsys Cortisol II, Cortisol II CalSet (2016), cited by 1
- K142723: ADVIA Centaur Cortisol (COR) Assy (2015), cited by 1
- K854419: TDX Cortisol (1985), cited by 1
- K062204: Architect Cortisol Assay (2006), cited by 1

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