510(k) Report

Devices descending from K012451

280 later devices reach Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+6K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+6K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+6K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+6K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+6K232915EpiMonitorEmpatica S.r.l.20241—
+6K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+6K231506Current Health SystemCurrent Health, Ltd.20230—
+6K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+6K223711ANNE OneSibel Health, Inc.20234—
+6K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+6K221530ANNE PediatricSibel, Inc.20220—
+6K213230T3 Platform SoftwareEtiometry, Inc.202212—
+6K202375ZOLL Propaq MZOLL Medical Corporation20211—
+6K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+6K191882Masimo Centroid SystemMasimo Corporation20203—
+6K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+6K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc.20192—
+6K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+6K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+6K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+6K172965Handheld VitalSigns Monitoring SystemVisiomed Technology Co.,Ltd20180—
+6K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+6K180472ViSi Mobile Monitoring SystemSotera Wireless, Inc.20181—
+6K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc.20150—
+7K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+7K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+7K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+7K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+7K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+7K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+7K252981EmbraceMiniEmpatica S.r.l.20251—
+7K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+7K250515EpiMonitorEmpatica S.r.l.20250—
+7K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+7K243837iBSMIorbit Digital Technologies Private Limited20250—
+7K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+7K242842ANNE View, Central HubSibel Health, Inc.20251—
+7K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+7K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+7K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+7K240251ANNE ChestSibel Health, Inc.20240—
+7K240305ANNE LimbSibel Health, Inc.20240—
+7K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+7K214115MightySat -OTCMasimo Corporation20241—
+7K223578T3 Platform softwareEtiometry, Inc.20232—
+7K223498Radius VSM and AccessoriesMasimo Corporation202312
+7K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+7K213423T3 Platform softwareEtiometry, Inc.20232—
+7K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+7K222463EchoGo Heart FailureUltromics Limited20227—
+7K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+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—
+7K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+7K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+7K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D…Vitalconnect, Inc.20201—
+7K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+7K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+7K181352Loop SystemSpry Health, Inc.201910—
+8K251293CardioVisionIcardio.Ai20250—
+8K250757Radius VSM and AccessoriesMasimo Corporation20250—
+8K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+8K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+8K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+8K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+8K232445CSF-4 (CSF-4)Cardiacsense20240—
+8K231531Pediarity™Hinlab, Inc.20230—
+8K223721Masimo StorkMasimo Corporation20230—
+8K223905Vivio® LVEDP SystemAvicena, LLC20230—
+8K231335Cleerly ISCHEMIACleerly, Inc.20230—
+8K231276SmartCardia 7L PlatformSmartcardia SA20230—
+8K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+8K220351Polso WatchChronisense Medical, Ltd.20220—
+8K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—
+9K254066Etiometry PlatformEtiometry, Inc.20260—
+9K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+9K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—