510(k) Report

Devices descending from K032363

114 later devices reach Zoll M Series Nibp Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120173Patient MonitorEdan Instruments, Inc.201210—
+1K113623Patient MonitorEdan Instruments, Inc.2012152
+1K090801Electronic House CallExpress MD Solutions, LLC20093—
+1K082599Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500ATCnsystem Medizintechnik AG200825—
+1K051907InnocorInnovision A/S20064—
+1K042007Zoll E Series DefibrillatorZoll Medical Corp2005643
+2K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+2K190561NICU V'02Cosmed Nordic Aps20200—
+2K183521CNAP MonitorCnsystems Medizintechnik GmbH20191—
+2K160981Patient MonitorEdan Instruments, Inc.201681
+2K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+2K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+2K130709Visi Mobile Monitoring SystemSotera Wireless, Inc.201319—
+2K102047Lci Option for InnocorInnovision A/S201101
+2K102063Health-E-Connect SystemAlr Technologies20111—
+2K102968Infinity Cnap SmartpodDraeger Medical Systems, Inc.20112—
+2K110168Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters201115—
+2K093895Ally Platform SystemContinuity Health Solutions20100—
+2K091265Zoll E Series with CprreadychargeZoll Medical Corporation, World Wide Headquarters20090—
+2K092598Zoll E Series with Spco/Spmet OptionZoll Medical Corporation, World Wide Headquarters20092—
+2K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp200927—
+2K081081Zoll E Series with Bluetooth Dial UP NetworkingZoll Medical Corporation, World Wide Headquarters20090—
+2K083879Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath…Innovision A/S20092—
+2K080903Zoll E Series with Intibation Assist OptionZOLL Medical Corporation20083—
+2K080232Zoll E Series 12SL, Analysis OptionZoll Medical Corporation, World Wide Headquarters20080—
+2K071911Cardiopulmonary Exercise Testing Option to InnocorInnovision A/S20073—
+2K060559Zoll R Series DefibrillatorZOLL Medical Corporation2006211
+3K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+3K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+3K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+3K192514Patient MonitorEdan Instruments, Inc.202061
+3K163664Health-e-Connect System with IDAAlr Technologies20170—
+3K161056Telemetry TransmitterEdan Instruments, Inc.201702
+3K152552Patient MonitorEdan Instruments, Inc.201621
+3K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+3K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorSotera Wireless, Inc.20150—
+3K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+3K143751Visi Mobile Monitoring SystemSotera Wireless, Inc.201517—
+3K140502Zoll E Series AlsZOLL Medical Corporation20141—
+3K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+3K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+3K122839Zoll Surepower Single Bay ChargerZOLL Medical Corporation20120—
+3K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+3K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters201110—
+3K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation201191
+3K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+3K081828Zoll R Series BLS DefibrillatorZOLL Medical Corporation20088—
+3K081574Zoll R SeriesZOLL Medical Corporation20088—
+4K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+4K202336Patient MonitorEdan Instruments, Inc.202131
+4K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+4K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+4K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+4K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+4K150992Vios Monitoring SystemVios Medical, Inc.20157—
+4K152341ViSi Mobile Monitoring SystemSotera Wireless, Inc.20154—
+4K151776Central Venous Pressure SystemMespere Lifesciences, Inc.20150—
+4K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.20150—
+4K150361ViSi Mobile Monitoring SystemSotera Wireless, Inc.20156—
+4K133239Zoll E SeriesZoll Medical Corporation, World Wide Headquarters20150—
+4K133441Onestep CPR II Multi-Function ElectrodeBio-Detek, Inc.20141—
+4K133484Zoll X SeriesZoll Medical Corp20141—
+4K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+4K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters20126—
+4K121367Zoll Propaq XMZOLL Medical Corporation201231
+4K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+4K110361Zoll R Series with 2010 Aha Guidelines Software UpdateZoll Medical Corporation, World Wide Headquarters20117—
+4K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+5K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+5K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+5K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+5K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+5K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+5K191882Masimo Centroid SystemMasimo Corporation20203—
+5K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+5K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+5K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+5K172965Handheld VitalSigns Monitoring SystemVisiomed Technology Co.,Ltd20180—
+5K180482ZOLL Propaq MZOLL Medical Corporation20182—
+5K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+5K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+5K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+5K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+5K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+5K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc.20150—
+5K142915ZOLL X SeriesZOLL Medical Corporation20140—
+5K141774Zoll X SeriesZOLL Medical Corporation20142—
+6K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+6K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+6K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+6K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+6K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+6K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+6K240251ANNE ChestSibel Health, Inc.20240—
+6K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+6K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+6K223498Radius VSM and AccessoriesMasimo Corporation202312
+6K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+6K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+6K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—