510(k) Report

Devices descending from K940013

102 later devices reach Body Position Indicator, Model BPI1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020607Sleepflo, Model 101501Biomec, Inc.200299—
+1K981969Ultima Body Position SensorBraebon Medical Corp.19981—
+2K191492Maxxi Position SensorNeurovirtual USA, Inc.20200—
+2K030379Aplab, Model 801D0030Sector Medical Corp.200398—
+3K041724Compass M10 SystemMedcare Flaga200441—
+3K041904Compass F10 SystemMedcare Flaga200454—
+3K040576Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH200431—
+4K122516Embletta MPREmbla Systems2013271
+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—
+5K242290DormoTech NLabDormotech Medical, Ltd.20250—
+5K210593Onera Sleep Test System (Onera STS)Onera B.V.20223—
+5K203343Wesper LabWesper, Inc.20211—
+5K161579Watch-PAT200UItamar Medical, Ltd.201720—
+5K143272ApneaLink AirResmed Germany, Inc.20157—
+5K124062QDC-Pro, and Nox-RipNox Medical20133—
+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—
+5K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+5K070263ApnealinkResmed Germany, Inc.200729—
+6K260050WRAP SystemHuneo, LLC20260—
+6K223573Onera Sleep Test System (Onera STS)Onera B.V.20231—
+6K221816Wesper LabWesper, Inc.20230—
+6K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+6K191031NightOwlEctosense NV20205—
+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—
+6K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+6K151361Nox RIP Belts & CablesNox Medical Ehf20152—
+6K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+6K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+6K131379EarlysenseEarlysense, Ltd.20137—
+6K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+6K111314Morpheus OXWidemed, Ltd.20110—
+6K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+6K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+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—
+7K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+7K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+7K242447Falcon HSTCompumedics Limited20250—
+7K231546SomfitCompumedics Limited20231—
+7K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+7K213463NightOwlEctosense NV20213—
+7K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+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—
+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—
+8K261360EasyCare Tx 2Resmed Corp20260—
+8K253274BedDot (G1)Intelligent Dots, LLC20260—
+8K252628CassieWesper, Inc.20260—
+8K251889myAirResmed Corp20260—
+8K252383Somfit DCompumedics Limited20250—
+8K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+8K231355AuroraEnsodata20240—
+8K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+8K220095ANNE SleepSibel, Inc.20224—
+8K220028NightOwlEctosense NV20222—
+8K203126S10 KirraResmed Pty, Ltd.20200—
+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—
+9K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+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—
+9K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+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—
+10K244027Sansa HsatHuxley Medical20252—
+10K241216myAirResmed Corp20242—
+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—
+11K252497Sansa HsatHuxley Medical20250—