510(k) Report

Devices descending from K022537

50 later devices reach Press-Mate PM-2100 Vital Sign Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc.20170—
+1K071645Model HBP T-105 Series, Model T-105 and T-105SOmron Healthcare, Inc.200728—
+1K032857Press-Mate BX-10 Vital Sign MonitorColin Medical Instruments Corp.200419—
+2K113623Patient MonitorEdan Instruments, Inc.2012152
+2K110922Patient MonitorEdan Instruments, Inc.201111
+2K082812Omron Model HBP-2070 Vital Signs MonitorOmron Healthcare, Inc.200827—
+2K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc.200801
+3K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+3K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+3K120631Patient MonitorAdvanced Instruments, Inc.20120—
+3K112478Visi Mobile Monitoring SystemSotera Wireless, Inc.2012242
+3K112190Patient MonitorMediana Co., Ltd.20110—
+3K100217Lucon M-Series Patient Monitor, Models M20 and M30Mediana Co., Ltd.20101—
+4K161056Telemetry TransmitterEdan Instruments, Inc.201702
+4K160981Patient MonitorEdan Instruments, Inc.201681
+4K152552Patient MonitorEdan Instruments, Inc.201621
+4K142087Cova Monitoring SystemTosense, Inc.20151—
+4K130709Visi Mobile Monitoring SystemSotera Wireless, Inc.201319—
+4K122036Visi Mobile Monitoring SystemSotera Wireless, Inc.2012202
+5K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+5K160899CoVa Monitoring System 2Tosense, Inc.20170—
+5K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera Wireless, Inc.20150—
+5K143751Visi Mobile Monitoring SystemSotera Wireless, Inc.201517—
+5K133586Visi Mobile Monitioring SystemSotera Wireless, Inc.201318—
+6K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K202336Patient MonitorEdan Instruments, Inc.202131
+6K150992Vios Monitoring SystemVios Medical, Inc.20157—
+6K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+6K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+7K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+7K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+7K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+7K172965Handheld VitalSigns Monitoring SystemVisiomed Technology Co.,Ltd20180—
+7K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+7K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+7K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+7K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+8K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+8K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+8K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+8K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+8K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+8K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+9K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+9K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+9K223721Masimo StorkMasimo Corporation20230—