510(k) Report

Devices descending from K062238

24 later devices reach Tytan Blood Pressure Cuff through their predicates, nearest generation first.

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