510(k) Report

Devices descending from K101533

6 later devices reach EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213917QStat CartridgeHemosonics, LLC20224—
+1K201440ROTEM sigma Thromboelastometry SystemTem Innovations GmbH20220—
+2K240045QStat CartridgeHemosonics, LLC20241—
+2K230461Quantra Hemostasis AnalyzerHemosonics, LLC20231—
+3K251404Quantra QStat CartridgeHemosonics, LLC20250—
+3K232215Quantra Hemostasis AnalyzerHemosonics, LLC20230—