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
+1K173793XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems20191—
+1K043132Universal XacttraceMedcare Flaga200410—
+1K040605Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix Reusable Limb…Dymedix, Inc.2004100—
+1K020607Sleepflo, Model 101501Biomec, Inc.200299—
+1K983449Gereonics Ultra-Piezo Respiratory Effort SensorGereonics, Inc.19990—
+2K242424Bluebird Single-Use Respiratory Effort BeltCadwell Industries, Inc.20240—
+2K113054EquivitalHidalgo Limited201271—
+2K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+2K061993Equivital, Model EQ-01Hidalgo Limited200699—
+2K030379Aplab, Model 801D0030Sector Medical Corp.200398—
+3K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+3K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc.201470—
+3K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+3K100040BioharnessZephyr Technology Corporation20103—
+3K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+3K081140VisensiaObs Medical200822—
+3K041724Compass M10 SystemMedcare Flaga200441—
+3K041904Compass F10 SystemMedcare Flaga200454—
+3K040576Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH200431—
+4K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+4K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+4K191870VV330 Continuous ECG Platform, VivaLNK Adhesive PatchVivaLNK, Inc.20200—
+4K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+4K152973Dyna-Vision Telemonitoring SystemTechmedic Development International B.V.20160—
+4K152258T3 SoftwareEtiometry, Inc.201616—
+4K150992Vios Monitoring SystemVios Medical, Inc.20157—
+4K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc.201543—
+4K142512Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)20153—
+4K122516Embletta MPREmbla Systems2013271
+4K113045BioharnessZephyr Technology Corporation20122—
+4K110953Visensia, Visensia with AlertObs Medical201117—
+4K092062Everon 1.0Earlysense, Ltd.201010—
+4K082113Nox T3, Noxturnal (PC Application)Nox Medical2008171
+4K073682Embletta GoldEmbla Systems, Inc.2008411
+4K073269HC1000P Sleep Diagnosis Software SystemHypnocore, Ltd.20080—
+4K061405Apnealink, Model 22302Resmed Germany, Inc.200630—
+5K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+5K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+5K242290DormoTech NLabDormotech Medical, Ltd.20250—
+5K210593Onera Sleep Test System (Onera STS)Onera B.V.20223—
+5K211365Alio Medical Remote Monitoring SystemGraftworx, Inc. Dba Alio20223—
+5K203343Wesper LabWesper, Inc.20211—
+5K200690LifeSignals ECG Remote Monitoring Patch PlatformLifesignals, Inc.20201—
+5K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+5K183282Biovitals Analytics EngineBiofourmis Singapore Pte., Ltd.20192—
+5K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+5K183322physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.20191—
+5K181196Caretaker Remote Display App and Caretaker Software LibraryCaretaker Medical, LLC20181—
+5K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+5K172011LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)Hmicro, Inc.20181—
+5K173510BioStamp nPointMc10, Inc.20180—
+5K172329Patient Status EngineIsansys Lifecare, Ltd.201810—
+5K163453VitalPatch® VitalConnect PlatformVitalconnect, Inc.201711—
+5K171244PhysiotraceNimbleheart, Inc.20170—
+5K170973VitalWatch Software User InterfaceVitalconnect, Inc.20171—
+5K163065T3 SoftwareEtiometry, Inc.201715—
+5K163255CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs…Caretaker Medical, LLC201715—
+5K161579Watch-PAT200UItamar Medical, Ltd.201720—
+5K143272ApneaLink AirResmed Germany, Inc.20157—
+5K124062QDC-Pro, and Nox-RipNox Medical20133—
+5K122763Physiological Data ProcessorZephyr Technology Corporation20130—
+5K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+5K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+5K092003CPC Sleep Data Recorder, Model M1, and Application SoftwareMyCardio, LLC20094—
+5K070263ApnealinkResmed Germany, Inc.200729—
+6K260050WRAP SystemHuneo, LLC20260—
+6K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.20260—
+6K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+6K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+6K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+6K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+6K241397HinscopeHinlab Sas20240—
+6K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+6K223573Onera Sleep Test System (Onera STS)Onera B.V.20231—
+6K230386SpassageQSpass, Inc.20231—
+6K223073AlioAlio, Inc.20230—
+6K221816Wesper LabWesper, Inc.20230—
+6K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+6K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+6K222550Current Health SystemCurrent Health, Ltd.20221—
+6K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+6K211305ANNE OneSibel, Inc.20216—
+6K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+6K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+6K202868LifeSignals Multi-Parameter Remote Monitoring PlatformLifesignals, Inc.20213—
+6K193415physIQ Heart Rhythm and Respiration ModulePhysiq, Inc.20200—
+6K191620Vitls PlatformVitls, Inc.20202—
+6K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2…Vitalconnect, Inc.202001
+6K191031NightOwlEctosense NV20205—
+6K190273T3 Platform softwareEtiometry, Inc.201914—
+6K190792BB-613WPBiobeat Technologies, Ltd.201912—
+6K191331Life Sensor Cardiac MonitorBraveheart Wireless, Inc.20190—
+6K183078VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc.20199—
+6K180775Watch-PAT300Itamar Medical, Ltd.201812—
+6K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+6K163696SleepImage SystemMycardio, LLC Dba Sleepimage.20173—
+6K163665MATRx plusZephyr Sleep Technologies20173—
+6K151361Nox RIP Belts & CablesNox Medical Ehf20152—
+6K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+6K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—