510(k) Report

Devices descending from K010686

26 later devices reach KTJ-20C Blood Pressure Cuff, Model KTJ-20C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051539Tricot Blood Pressure CuffYa Horng Electronic Co., Ltd.200525—
+2K062238Tytan Blood Pressure CuffTytan Medical Corp.200624—
+3K102825Blood Pressure CuffAPK Technology Co., Ltd.201123—
+4K133117Andon Blood Pressure CuffAndon Health Co, Ltd.20144—
+4K120173Patient MonitorEdan Instruments, Inc.201210—
+4K113623Patient MonitorEdan Instruments, Inc.2012152
+5K233276Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd.20231—
+5K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+5K171889Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd.20172—
+5K160981Patient MonitorEdan Instruments, Inc.201681
+5K151810Bpump Blood Pressure CuffShenzhen Pump Medical System Co., Ltd.20150—
+5K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+5K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+6K254287Medline Reusable Blood Pressure CuffMedline Industries, LP20260—
+6K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+6K192514Patient MonitorEdan Instruments, Inc.202061
+6K161056Telemetry TransmitterEdan Instruments, Inc.201702
+6K152552Patient MonitorEdan Instruments, Inc.201621
+7K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+7K202336Patient MonitorEdan Instruments, Inc.202131
+7K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+8K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+8K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+8K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+9K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+9K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—