510(k) Report

Devices descending from K923402

205 later devices reach Crystal Trace Piezo Respiratory Effort Sensor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K131379EarlysenseEarlysense, Ltd.20137—
+6K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+6K111314Morpheus OXWidemed, Ltd.20110—
+6K083575Apnealink Plus, Model: 22328Resmed Germany, Inc.200927—
+7K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH20260—
+7K243220Onera STS 2 (ONERA STS 2)Onera B.V.20250—
+7K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+7K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+7K242447Falcon HSTCompumedics Limited20250—
+7K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+7K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+7K240558NavoycdsAlgodx AB20240—
+7K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+7K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+7K232915EpiMonitorEmpatica S.r.l.20241—
+7K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+7K231546SomfitCompumedics Limited20231—
+7K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+7K231506Current Health SystemCurrent Health, Ltd.20230—
+7K223711ANNE OneSibel Health, Inc.20234—
+7K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+7K221530ANNE PediatricSibel, Inc.20220—
+7K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+7K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+7K213463NightOwlEctosense NV20213—
+7K202306T3 Platform softwareEtiometry, Inc.202013—
+7K192624ApneaTrakCadwell Industries, Inc.20200—
+7K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+7K182618SleepImage SystemMycardio, LLC Dba Sleepimage.20192—
+7K171304Maxxi Rip SensorNeurovirtual USA, Inc.20190—
+7K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc.20192—
+7K183559WatchPAT ONEItamar Medical, Ltd.20195—
+7K181996MATRx PlusZephyr Sleep Technologies20182—
+7K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+7K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+7K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—
+7K140124S9 EloueraResmed Corp20148—
+7K132371Easycare OnlineResmed, Ltd.20138—
+7K131932Apnealink ProResmed Germany, Inc.20138—
+8K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+8K261360EasyCare Tx 2Resmed Corp20260—
+8K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+8K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+8K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+8K253274BedDot (G1)Intelligent Dots, LLC20260—
+8K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+8K252628CassieWesper, Inc.20260—
+8K251889myAirResmed Corp20260—
+8K252981EmbraceMiniEmpatica S.r.l.20251—
+8K252383Somfit DCompumedics Limited20250—
+8K250515EpiMonitorEmpatica S.r.l.20250—
+8K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+8K243837iBSMIorbit Digital Technologies Private Limited20250—
+8K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+8K242842ANNE View, Central HubSibel Health, Inc.20251—
+8K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+8K240251ANNE ChestSibel Health, Inc.20240—
+8K240305ANNE LimbSibel Health, Inc.20240—
+8K231355AuroraEnsodata20240—
+8K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+8K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+8K220095ANNE SleepSibel, Inc.20224—
+8K213230T3 Platform SoftwareEtiometry, Inc.202212—
+8K220028NightOwlEctosense NV20222—
+8K203126S10 KirraResmed Pty, Ltd.20200—
+8K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D…Vitalconnect, Inc.20201—
+8K191925MATRx PlusZephyr Sleep Technologies20191—
+8K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+8K160836Menai SystemResmed, Ltd.20166—
+8K152356SapphireRespironics, Inc.20164—
+8K151901AirViewResmed, Ltd.20151—
+9K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)20260—
+9K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+9K242485EveryWareBreas Medical AB20250—
+9K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+9K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+9K231276SmartCardia 7L PlatformSmartcardia SA20230—
+9K223578T3 Platform softwareEtiometry, Inc.20232—
+9K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+9K213423T3 Platform softwareEtiometry, Inc.20232—
+9K222463EchoGo Heart FailureUltromics Limited20227—
+9K211155Auto CPAP SystemBMC Medical Co., Ltd.20220—
+9K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+9K200565GalapogosResmed Corp20213—
+9K200695MATRx plusZephyr Sleep Technologies20200—
+9K183226Care Orchestrator EssenceRespironics, Inc.20190—
+9K181053Care OrchestratorRespironics, Inc.20191—
+10K254042WatchPAT SWItamar Medical, Ltd.20260—
+10K251293CardioVisionIcardio.Ai20250—
+10K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+10K244027Sansa HsatHuxley Medical20252—
+10K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+10K241216myAirResmed Corp20242—
+10K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+10K223905Vivio® LVEDP SystemAvicena, LLC20230—
+10K231335Cleerly ISCHEMIACleerly, Inc.20230—
+10K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—
+10K201439Ventilator, Non-continuous (Respirator)Respironics, Inc.20200—
+11K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+11K254066Etiometry PlatformEtiometry, Inc.20260—