# K250965: Automated Blood Coagulation Analyzer CN-Series (CN-6000)

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: Jun 2, 2025 after 63 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011235 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150678: Sysmex Automated Blood Coagulation Analyzer CS-5100, Siemens Healthcare Diagnostic Products GmbH (2016) Summary page 5.

## Indications for use
The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laboratory. The instrument analyzes citrated plasma samples (3.2 % sodium citrate) collected from venous blood, using clotting, chromogenic and immunoassay methods. The performance of this device has not been established in neonate and pediatric patient populations

Source page: https://510kreport.com/device/K250965
Methodology: https://510kreport.com/methodology