# K223635: Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer

- Pathway: 510(k) (Special)
- Applicant: Sienco, Inc.
- Decided: Jan 4, 2023 after 30 days
- Product code: JBP (Activated Whole Blood Clotting Time)
- Device class: 2
- Regulation: 21 CFR 864.7140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952560 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002528: Sonoclot Coagulation & Platelet Function Analyzer System with Signature Viewer Option, Sienco, Inc. (2000) Summary page 4.
- K952560: Sonoclot Coagulation & Platelet Function Analyzer, Sienco, Inc. (1995) Summary page 4.

## Indications for use
The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software. The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis. The Sonoclot Analyzer System generates a qualitative graph, known a the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.

Source page: https://510kreport.com/device/K223635
Methodology: https://510kreport.com/methodology