510(k) Report

Devices descending from K915856

245 later devices reach Sensormedics 4000 Series Sleep System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012085Somno Star & Series Sleep SystemSensor Medics Corp.200199—
+1K000253Silent Night VSleep Solutions, Inc.200069—
+1K981034Silent Night IISleep Solutions, Inc.199896—
+1K971813EMBLAFerguson Medical199861—
+1K955841Sleep System for Clinics & ResearchCompumedics Ptd, Ltd.199763—
+2K162140RemLogicEmbla Systems20160—
+2K110486AccusomNovasom, Inc.20111—
+2K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd.201123—
+2K093223Compumedics Grael System, Models: Grael, Grael EcgCompumedics Limited20101—
+2K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+2K080427Watch-Pat Model 100S-2Itamar Medical200825—
+2K072201Compumedics Somte PSG Recording SystemCompumedics Limited200848—
+2K070375Earlysense ES-16 SystemEarlysense, Ltd.200723—
+2K072014VitascoreVitascore B.V.200740—
+2K070326Noga Automated Sleep Study Scoring and Data Management SystemWidemed, Ltd.20072—
+2K042745Lifescreen ApneaDel Mar Reynolds Medical, Inc.2005631
+2K030379Aplab, Model 801D0030Sector Medical Corp.200398—
+2K022506Morpheus 1, Automated Sleep Study Scoring & Data Management SystemWidemed, Ltd.200329—
+2K991446Biosaca System, Model 800Biosys AB (Publ)19990—
+2K984580Biosaca SystemBiosys AB (Publ)19991—
+3K230073OktiCompumedics Limited20230—
+3K220012BresoDX1Bresotec, Inc.20220—
+3K192469Nox Sleep SystemNox Medical20194—
+3K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+3K133859Watch-PAT200U (WP200U)Itamar Medical, Ltd.201422—
+3K112102Michele Sleep Scoring SystemsYounes Sleep Technologies201118—
+3K111314Morpheus OXWidemed, Ltd.20110—
+3K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+3K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201140—
+3K110001Spacelabs Pathfinder SL Holter AnalyzerSpacelabs Healthcare, Ltd.201161
+3K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+3K082465EveronEarlysense, Ltd.200911—
+3K083325N-600X with SPD, Oximax N-600XCovidien200953—
+3K083620Somnolyzer 24X7The Siesta Group North America200925—
+3K082626PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd.200921—
+3K082968Apneicare Connection Center/Internet AnalysisApneicare, LLC200939—
+3K081861Holter LX AnalysisNorth East Monitoring, Inc.20080—
+3K081982Watch-Pat 200S-2 (WP200S-2)Itamar Medical200824—
+3K073269HC1000P Sleep Diagnosis Software SystemHypnocore, Ltd.20080—
+3K070855Sleep QualityDynadx Corporation20080—
+3K041724Compass M10 SystemMedcare Flaga200441—
+3K041904Compass F10 SystemMedcare Flaga200454—
+3K040576Micromesam Basic-SetMap Medizintechnik Fur Arzt Und Patient GmbH200431—
+4K252330DeepRESPNox Medical Ehf20250—
+4K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+4K241960DeepRESPNox Medical Ehf20251—
+4K223539Dreem 3SBeacon Biosignals, Inc.20231—
+4K223922Somnum (V.1.1.2.)Honeynaps Co., Ltd.20231—
+4K213007Cerebra Sleep SystemCerebra Medical, Ltd.20220—
+4K202464Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc.20219—
+4K201921Spacelabs Lifescreen PRO AnalyzerSpacelabs Healthcare, Ltd.20210—
+4K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+4K160499Apnea Risk Evaluation System (ARES), Model 620Watermark Medical20170—
+4K161579Watch-PAT200UItamar Medical, Ltd.201720—
+4K153070Watch-PAT200UItamar Medical, Ltd.20160—
+4K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+4K131994Somnolyzer 24X7Respironics, Inc.20135—
+4K122516Embletta MPREmbla Systems2013271
+4K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+4K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+4K120450Sleep ProfilerAdvanced Brain Monitoring, Inc.201216—
+4K120773Nellcor Bedside SPO2 Patient Monitoring SystemCovidien, LLC201261
+4K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+4K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc.201238—
+4K110569Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Inovise Medical, Inc.20114—
+4K092062Everon 1.0Earlysense, Ltd.201010—
+4K082113Nox T3, Noxturnal (PC Application)Nox Medical2008171
+4K073682Embletta GoldEmbla Systems, Inc.2008411
+4K061405Apnealink, Model 22302Resmed Germany, Inc.200630—
+5K253390Somnum (Somnum)Honeynaps Co., Ltd.20260—
+5K253274BedDot (G1)Intelligent Dots, LLC20260—
+5K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+5K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+5K242798AirmodHeroic Faith International, Ltd.20251—
+5K242290DormoTech NLabDormotech Medical, Ltd.20250—
+5K242094Dreem 3SBeacon Biosignals, Inc.20240—
+5K234003The Circadia C200 SystemCircadia Technologies, Ltd.20242—
+5K223163Sleepiz One+Sleepiz AG20233—
+5K212143Neteera 130H/131H Vital Sign Monitoring SensorNeteera Technologies, Ltd.20221—
+5K210593Onera Sleep Test System (Onera STS)Onera B.V.20223—
+5K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+5K203343Wesper LabWesper, Inc.20211—
+5K191031NightOwlEctosense NV20205—
+5K180775Watch-PAT300Itamar Medical, Ltd.201812—
+5K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+5K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+5K143272ApneaLink AirResmed Germany, Inc.20157—
+5K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+5K142988Sleepware G3Respironics, Inc.20154—
+5K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+5K142825ZmachineConsolidated Research of Richmond, Inc.20150—
+5K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+5K140190Night ShiftAdvanced Brain Monitoring, Inc.20141—
+5K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+5K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+5K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+5K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+5K124062QDC-Pro, and Nox-RipNox Medical20133—
+5K130007Sleep ProfilerAdvanced Brain Monitoring, Inc.201314—
+5K130013X4 SystemAdvanced Brain Monitoring, Inc.201317—