510(k) Report

Devices descending from K001814

127 later devices reach Datex-Ohmeda Compact Airway Module M-Caiovx and M-Covx (Version 01) and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081601Veo Multigas Monitor for Pocket PCPhasein AB200812—
+1K062754Gas Module SE, Model 0998-00-0481-02Datascope Corp.200621
+1K051092Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov…GE Healthcare20051182
+1K023454Datex-Ohmeda S/5 Single-Width Airway Module M-Minic and AccessoriesDatex-Ohmeda200313—
+2K190824Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling…Bluepoint Medical GmbH & Co. KG20190—
+2K180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+2K150245CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVXGE Healthcare Finland Oy20153Class I
+2K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150—
+2K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+2K123195Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesGE Healthcare Finland Oy201313Class I
+2K123043Irma C02 Model 200101; Irma AX 200601Phasein AB201211—
+2K103604Isa CO2, Isa AX+, Isa or+Phasein AB201191—
+2K093080Metaphor Metabolic MonitorTreymed, Inc.20100—
+2K062324Mri Monitor with L-CANE05 and L-CANE05A Software and Module Options N-Psngv, N-PSNG…GE Healthcare20060—
+2K053599Spacelabs Medical Multigas Analyzer Module 91518 and AccessoriesSpacelabs Medical, Inc.200632
+2K052582Datex-Ohmeda S/5 Single-Width Airway Module, E-Minic and AccessoriesGE Healthcare20050Class I
+2K051857Veo Multigas Monitor for Pocket PC, Model 400221Weissburg Associates200516—
+2K043276Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec ModuleDatex-Ohmeda200411Class I
+3K250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.20250—
+3K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and…GE Healthcare Finland Oy20172Class I
+3K160481Vivo 60Breas Medical AB201672
+3K140264MADMThornhill Research, Inc.20150—
+3K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+3K140430740 SelectCas Medical Systems, Inc.20141—
+3K130584Monitor B40Ge Medical Systems China Co., Ltd.201382
+3K120598Procare Monitor B40Ge Medical Systems China Co., Ltd.2012102
+3K120173Patient MonitorEdan Instruments, Inc.201210—
+3K113623Patient MonitorEdan Instruments, Inc.2012152
+3K112173Speacelabs Multigas ModuleSpacelabs Healthcare201121
+3K063167Emma Analyzer (Kpa) and (MMHG); Emma Monitor (Kpa) and (MMHG)Phasein AB20072—
+4K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15Caf Medical Solutions, Inc.20220—
+4K193586Vivo 45 LSBreas Medical AB20212Class I
+4K181170Trilogy Evo UniversalRespironics, Inc.20190Class I
+4K181166Trilogy EvoRespironics, Inc.20195Class I
+4K183394CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiOGE Healthcare Finland Oy20191Class I
+4K172890SedLine Sedation MonitorMasimo Corporation20185—
+4K160981Patient MonitorEdan Instruments, Inc.201681
+4K150620740 SelectCas Medical Systems, Inc.201501
+4K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+4K132077Patient MonitorAdvanced Instrumentations, Inc.20140—
+4K131971IM60/IM70 Patient MonitorEdan Instruments, Inc.2014142
+4K133576Monitor B40Ge Medical Systems China Co., Ltd.20147Class I
+4K122253Procare Monitor B20Ge Medical Systems China Co., Ltd.201302
+4K121017Capnography Pad (92516)Spacelabs Healthcare20121—
+4K072813Emma Analyzer (Kpa & MMHG); Emma Monitor (Kpa & MMHG)Phasein AB20071—
+5K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+5K233452Vivo 45 LSBreas Medical AB202501
+5K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+5K240807VM-2000Ventis Medical, Inc.20240—
+5K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+5K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17Caf Medical Solutions, Inc.20220—
+5K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+5K211171CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX…GE Healthcare Finland Oy20210—
+5K201590EMMA CapnographMasimo Corporation20210—
+5K192514Patient MonitorEdan Instruments, Inc.202061
+5K161056Telemetry TransmitterEdan Instruments, Inc.201702
+5K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+5K152552Patient MonitorEdan Instruments, Inc.201621
+5K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+5K151063Monitor B40Ge Medical Systems China Co., Ltd.201551
+5K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+5K143676B40i Patient MonitorGE Healthcare Finland Oy201541
+5K130112Capno Module, 92517Spacelabs Healthcare20130—
+6K260880SedLine Sedation MonitorMasimo Corporation20260—
+6K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+6K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+6K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+6K202336Patient MonitorEdan Instruments, Inc.202131
+6K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+6K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+6K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+6K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+6K171580Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.201741
+6K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+7K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+7K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+7K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+7K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+7K214115MightySat -OTCMasimo Corporation20241—
+7K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+7K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+7K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+7K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+7K191882Masimo Centroid SystemMasimo Corporation20203—
+7K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+7K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+7K181352Loop SystemSpry Health, Inc.201910—
+7K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+8K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+8K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+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—
+8K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+8K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+8K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+8K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+8K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+8K240251ANNE ChestSibel Health, Inc.20240—