510(k) Report

Devices descending from K002177

14 later devices reach Thrombelastograph Coagulation Analyzer Teg-5000 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183160TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeHaemonetics Corporation201901
+1K150041CORA (Coagulation Resonance Analysis) SystemCoramed Technologies, LLC20154—
+1K101533EX-Tem. Fib-Tem, and AP-Tem for Rotem Delta Thromboelastometry SystemTem Innovations GmbH201165
+1K083842Rotem Delta Thromboelastometry SystemPentapharm GmbH201062
+2K243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics Corporation20251—
+2K232018Citrated: K, KH, RTH, FFHHaemonetics Corporation20240—
+2K213917QStat CartridgeHemosonics, LLC20224—
+2K201440ROTEM sigma Thromboelastometry SystemTem Innovations GmbH20220—
+2K160502TEG 6s Hemostasis SystemHaemonetics Corporation20170—
+3K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics20250—
+3K240045QStat CartridgeHemosonics, LLC20241—
+3K230461Quantra Hemostasis AnalyzerHemosonics, LLC20231—
+4K251404Quantra QStat CartridgeHemosonics, LLC20250—
+4K232215Quantra Hemostasis AnalyzerHemosonics, LLC20230—