# GKP: Instrument, Coagulation, Automated

- Device class: 2; regulation: 21 CFR 864.5400; FDA's rule: 510(k) required
- FDA decisions: 49
- 510(k) review time 2021–2025: median 50 days (middle half 39–60)
- Recalls: 10 (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)
- 2002: 2
- 2003: 1
- 2004: 1
- 2007: 1
- 2008: 1
- 2009: 1
- 2015: 1
- 2016: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K964139: Sysmex CA-6000 (1997), cited by 6
- K884863: Electra 900C Automatic Coagulation Timer (1989), cited by 6
- K073377: Acl Top (with System Software V3.0.0) (2008), cited by 4
- K033414: Acl Top Model, Top (2004), cited by 3
- K894052: Electra 1000C Automatic Coagulation Timer (1989), cited by 3
- K150877: Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top 750; Acl Top 750 CTS; Acl Top 750 Las (2015), cited by 3
- K001145: Sysmex Automated Coagulation Analyzer, Model CA-6000 (2000), cited by 2
- K992321: Sysmex Automated Coagulation Analyzer, Model CA-6000 (1999), cited by 2
- K160276: Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS) (2016), cited by 2
- K091980: Acl Top 700 Las (2009), cited by 2

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