510(k) Report

Devices descending from K971867

105 later devices reach Alice 4R System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040595ALICE 5Respironics, Inc.2004401
+1K990199Smartrecorder, Model 2500Respironics, Inc.19990—
+1K983572Simon Multichannel Recording System, Model 5500Healthdyne Technologies, Inc.19991—
+1K971813EMBLAFerguson Medical199861—
+2K201054SOMNOscreen plusSomnomedics GmbH20204—
+2K162140RemLogicEmbla Systems20160—
+2K133995Neuron-Spectrum-4/P with Neuron-Spectrum.Net SoftwareNeurosoft, Ltd.20151—
+2K142988Sleepware G3Respironics, Inc.20154—
+2K111055Galaxy System; JupiterPersonal Health Institute International20110—
+2K112102Michele Sleep Scoring SystemsYounes Sleep Technologies201118—
+2K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd.201123—
+2K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+2K080427Watch-Pat Model 100S-2Itamar Medical200825—
+2K070375Earlysense ES-16 SystemEarlysense, Ltd.200723—
+2K070326Noga Automated Sleep Study Scoring and Data Management SystemWidemed, Ltd.20072—
+2K061996Sandman PocketEb Neuro S.P.A.20067—
+2K991446Biosaca System, Model 800Biosys AB (Publ)19990—
+2K984580Biosaca SystemBiosys AB (Publ)19991—
+3K250851Hypnos (369054-200)Cadwell Industries, Inc.20250—
+3K241288Noxturnal WebNox Medical Ehf20242—
+3K240700HomeSleepTest (HST, HST REM+)Somnomedics GmbH20240—
+3K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+3K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft, Ltd.20220—
+3K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—
+3K202142Sleepware G3Respironics, Inc.20202—
+3K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+3K133859Watch-PAT200U (WP200U)Itamar Medical, Ltd.201422—
+3K120450Sleep ProfilerAdvanced Brain Monitoring, Inc.201216—
+3K111314Morpheus OXWidemed, Ltd.20110—
+3K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+3K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+3K093728BE Micro, TreaEb Neuro S.P.A.20104—
+3K082465EveronEarlysense, Ltd.200911—
+3K082853Clinical Oxygen Dose Recorder (Codr), Model 300-CRInspired Technologies, Inc.20090—
+3K083874GalaxyRespironics Inc., Sleep & Home Respiratory Group20090—
+3K082626PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd.200921—
+3K081982Watch-Pat 200S-2 (WP200S-2)Itamar Medical200824—
+3K073269HC1000P Sleep Diagnosis Software SystemHypnocore, Ltd.20080—
+4K261747Report StudioBeacon Biosignals, Inc.20260—
+4K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+4K260585Noxturnal WebNox Medical Ehf20260—
+4K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+4K241960DeepRESPNox Medical Ehf20251—
+4K202464Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc.20219—
+4K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+4K161579Watch-PAT200UItamar Medical, Ltd.201720—
+4K153070Watch-PAT200UItamar Medical, Ltd.20160—
+4K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+4K142825ZmachineConsolidated Research of Richmond, Inc.20150—
+4K133355Cadwell Flex Eeg/PSGCadwell Industries, Inc.20143—
+4K130007Sleep ProfilerAdvanced Brain Monitoring, Inc.201314—
+4K092062Everon 1.0Earlysense, Ltd.201010—
+5K253274BedDot (G1)Intelligent Dots, LLC20260—
+5K252330DeepRESPNox Medical Ehf20250—
+5K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+5K234003The Circadia C200 SystemCircadia Technologies, Ltd.20242—
+5K223163Sleepiz One+Sleepiz AG20233—
+5K212143Neteera 130H/131H Vital Sign Monitoring SensorNeteera Technologies, Ltd.20221—
+5K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+5K191031NightOwlEctosense NV20205—
+5K180775Watch-PAT300Itamar Medical, Ltd.201812—
+5K180269Cadwell Apollo SystemCadwell Industries, Inc.20182—
+5K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+5K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+5K153412Sleep ProfilerAdvanced Brain Monitoring, Inc.201613—
+5K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+6K254058DistaSense (TM) (v1)Life Detection Technologies20260—
+6K260050WRAP SystemHuneo, LLC20260—
+6K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+6K252676The Circadia C300 System (C300)Circadia Health, Inc.20261—
+6K251364Sleepiz One+ (2.5)Sleepiz AG20251—
+6K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+6K233438SleepStageMLBeacon Biosignals, Inc.20240—
+6K231733Neteera 130H-Plus Vital Sign Monitoring SensorNeteera Technologies, Ltd.20240—
+6K231546SomfitCompumedics Limited20231—
+6K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+6K213463NightOwlEctosense NV20213—
+6K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+6K201819Cadwell Apollo SystemCadwell Industries, Inc.20201—
+6K183559WatchPAT ONEItamar Medical, Ltd.20195—
+6K182227Esprit NovaNeurozone Msh Incorporated20190—
+6K162627EnsoSleepEnsodata, Inc.20179—
+6K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+6K131379EarlysenseEarlysense, Ltd.20137—
+7K261286The Circadia C300 System (C300)Circadia Health, Inc.20260—
+7K253668Onera SleepMap (SLEEPMAP)Onera B.V.20260—
+7K253388Sleepiz One+ (Model 2.5)Sleepiz AG20260—
+7K252383Somfit DCompumedics Limited20250—
+7K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC20250—
+7K221959Q21Neurofield, Inc.20230—
+7K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+7K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—
+7K221179SomnoMetryNeumetry Medical, Inc.20223—
+7K220095ANNE SleepSibel, Inc.20224—
+7K220028NightOwlEctosense NV20222—
+7K210034EnsoSleepEnsodata, Inc.20210—
+7K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+8K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+8K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+8K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—