# K031377: Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and -560

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 8, 2003 after 130 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
Longest line of descent: 4 generations back to K926551 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020979: Sysmex Automated Coagulation Analyzer, Model #CA-7000, Dade Behring, Inc. (2002) Summary page 1.
- K964139: Sysmex CA-6000, Dade Intl., Inc. (1997) Summary page 1.

## Indications for use
The intended use of the Sysmex CA-500 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument uses citrated human plasma to perform coagulation tests.

Source page: https://510kreport.com/device/K031377
Methodology: https://510kreport.com/methodology