# K952560: Sonoclot Coagulation & Platelet Function Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Sienco, Inc.
- Decided: Sep 5, 1995 after 95 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sonoclot Analyzer: named in the summary without a submission number

## Most influential descendants
- K223635: Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (2023), 0 descendants of its own
- K032952: Aiact Kit (2003), 0 descendants of its own
- K984141: Gbact + Kit (1999), 0 descendants of its own

## Indications for use
The Sonoclot Coagulation & Platelet Function Analyzer is an instrument for the in vitro measuring of coagulation and platelet function. The Sonoclot Analyzer performs in vitro whole blood and plasma analyses.

Source page: https://510kreport.com/device/K952560
Methodology: https://510kreport.com/methodology