# K001145: Sysmex Automated Coagulation Analyzer, Model CA-6000

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: May 11, 2000 after 31 days
- Product code: GKP (Instrument, Coagulation, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020979: Sysmex Automated Coagulation Analyzer, Model #CA-7000 (2002), 1 descendant of its own
- K031377: Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and -560 (2003), 0 descendants of its own
- K013114: BCS System (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K001145
Methodology: https://510kreport.com/methodology