510(k) Report

Devices descending from K032857

19 later devices reach Press-Mate BX-10 Vital Sign Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113623Patient MonitorEdan Instruments, Inc.2012152
+1K110922Patient MonitorEdan Instruments, Inc.201111
+1K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.200801
+2K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+2K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+2K120631Patient MonitorAdvanced Instruments, Inc.20120—
+3K161056Telemetry TransmitterEdan Instruments, Inc.201702
+3K160981Patient MonitorEdan Instruments, Inc.201681
+3K152552Patient MonitorEdan Instruments, Inc.201621
+4K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+4K192514Patient MonitorEdan Instruments, Inc.202061
+4K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+5K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+5K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+5K202336Patient MonitorEdan Instruments, Inc.202131
+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—