# K011235: Sysmex Automated Coagulation Analyzer / Model # CA-1500

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 20, 2001 after 88 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
No predicates in its family tree.
9 later devices descend from it; 8 cite it directly.
0 of 10 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
- K150678: Sysmex Automated Blood Coagulation Analyzer CS-5100 (2016), 1 descendant of its own
- K250965: Automated Blood Coagulation Analyzer CN-Series (CN-6000) (2025), 0 descendants of its own
- K172286: Automated Blood Coagulation Analyzer CS-2500 (2017), 0 descendants of its own
- K172333: Sysmex CS-5100 (2017), 0 descendants of its own
- K162688: Sysmex CS-2100i (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K011235
Methodology: https://510kreport.com/methodology