# GJS: Test, Time, Prothrombin

- Device class: 2; regulation: 21 CFR 864.7750; FDA's rule: 510(k) required
- FDA decisions: 127
- 510(k) review time 2021–2025: median 299 days (middle half 60–399)
- Recalls: 49 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 1
- 2016: 1
- 2017: 1
- 2018: 2
- 2019: 2
- 2020: 1
- 2022: 3
- 2023: 2
- 2024: 1
- 2025: 3

## Most-cited predicates
- K060978: Coaguchek XS System (2006), cited by 5
- K071041: Coaguchek XS Plus System (2007), cited by 4
- K940082: Thromboscreen Thromboplastin-DS (1995), cited by 3
- K072727: Inratio 2 PT Monitoring System (2007), cited by 3
- K180780: microINR System (2019), cited by 3
- K931118: Assess (TM) High Abnormal Control (1994), cited by 2
- K201185: microINR System (2020), cited by 2
- K931117: Assess (TM) Low Abnormal Control (1994), cited by 2
- K020831: PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and 3271404 (2002), cited by 2
- K882456: Coag-I PT Test Card (1988), cited by 2

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