# K253658: STA Satellite Max®

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostica Stago, Inc.
- Decided: Apr 27, 2026 after 158 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082248: Sta Satellite Automated Multi-Parameter Analyzer, Diagnostica Stago, Inc. (2008) Summary page 5.

## Indications for use
The STA Satellite Max® is a fully automatic clinical analyzer intended to be used by professional laboratory personnel for qualitative and/or quantitative in vitro determination and to perform clotting, chromogenic and immunoassay tests on human venous plasmas (3.2% citrate) the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Source page: https://510kreport.com/device/K253658
Methodology: https://510kreport.com/methodology