# K151867: Sta R Max

- Pathway: 510(k) (Special)
- Applicant: Diagnostica Stago S.A.S
- Decided: Aug 7, 2015 after 29 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K942117 (1995). 4 ancestors in all.
1 later device descends 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)
- K093001: Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric Analyzer, Diagnostica Stago, Incorporated (2009) Summary page 5.

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

## Recalls of this device
- Mar 22, 2023 · Class II · Z-1575-2023: An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error r

## Indications for use
The STA R Max® is a fully 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/K151867
Methodology: https://510kreport.com/methodology