510(k) Report

Devices descending from K042417

238 later devices reach Zoll M Series ETC02 Loflo Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K230842SignalHF (IM008)Implicity, Inc.20230—
+8K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+8K220308Patient Monitor: RespArrayEdan Instruments, Inc.20221—
+8K221203AHI SystemFifth Eye, Inc.20220—
+8K212227Philips MR Patient Care PortalInvivo Corporation202101
+8K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+8K202336Patient MonitorEdan Instruments, Inc.202131
+8K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+8K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+8K192595ExSpiron 2XiRespiratory Motion20190—
+8K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+8K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+8K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+9K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+9K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+9K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+9K241397HinscopeHinlab Sas20240—
+9K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+9K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+9K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+9K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+9K222550Current Health SystemCurrent Health, Ltd.20221—
+9K212271smart-syncNorthh Medical GmbH20220—
+9K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+9K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+10K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+10K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+10K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+10K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+10K232915EpiMonitorEmpatica S.r.l.20241—
+10K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+10K231506Current Health SystemCurrent Health, Ltd.20230—
+11K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+11K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+11K252981EmbraceMiniEmpatica S.r.l.20251—
+11K250515EpiMonitorEmpatica S.r.l.20250—
+11K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+11K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—