# K093001: Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric Analyzer

- Pathway: 510(k) (Special)
- Applicant: Diagnostica Stago, Incorporated
- Decided: Dec 18, 2009 after 81 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: 3 generations back to K942117 (1995). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082675: Sta-R Evolution Automated Multi-Parametric Analyzer, Diagnostica Stago, Inc. (2008) Summary page 1.

## Most influential descendants
- K151867: Sta R Max (2015), 1 descendant of its own
- K212183: STA R Max 3, STA Compact Max 3 (2023), 0 descendants of its own

## Indications for use
STA-R Evolution® Expert Series Hemostasis System is a frully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Source page: https://510kreport.com/device/K093001
Methodology: https://510kreport.com/methodology