510(k) Report

Devices descending from K963597

97 later devices reach Silent Night I through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981034Silent Night IISleep Solutions, Inc.199896—
+2K080427Watch-Pat Model 100S-2Itamar Medical200825—
+2K000253Silent Night VSleep Solutions, Inc.200069—
+3K110486AccusomNovasom, Inc.20111—
+3K081982Watch-Pat 200S-2 (WP200S-2)Itamar Medical200824—
+3K070326Noga Automated Sleep Study Scoring and Data Management SystemWidemed, Ltd.20072—
+3K042745Lifescreen ApneaDel Mar Reynolds Medical, Inc.2005631
+4K220012BresoDX1Bresotec, Inc.20220—
+4K111314Morpheus OXWidemed, Ltd.20110—
+4K110001Spacelabs Pathfinder SL Holter AnalyzerSpacelabs Healthcare, Ltd.201161
+4K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd.201123—
+4K083325N-600X with SPD, Oximax N-600XCovidien200953—
+4K081861Holter LX AnalysisNorth East Monitoring, Inc.20080—
+4K073269HC1000P Sleep Diagnosis Software SystemHypnocore, Ltd.20080—
+4K070855Sleep QualityDynadx Corporation20080—
+5K201921Spacelabs Lifescreen PRO AnalyzerSpacelabs Healthcare, Ltd.20210—
+5K133859Watch-PAT200U (WP200U)Itamar Medical, Ltd.201422—
+5K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+5K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+5K120773Nellcor Bedside SPO2 Patient Monitoring SystemCovidien, LLC201261
+5K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien201249—
+5K110569Audicor Cpam (Cardiopulmonary Ambulatory Monitor)Inovise Medical, Inc.20114—
+6K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+6K242798AirmodHeroic Faith International, Ltd.20251—
+6K161579Watch-PAT200UItamar Medical, Ltd.201720—
+6K153070Watch-PAT200UItamar Medical, Ltd.20160—
+6K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+6K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+6K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+6K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+6K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+6K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+6K131085Central Venous Pressure System - Mespere Venus 1000Mespere Lifesciences, Inc.20131—
+7K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+7K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+7K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+7K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+7K191031NightOwlEctosense NV20205—
+7K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+7K180775Watch-PAT300Itamar Medical, Ltd.201812—
+7K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+7K152659V10Mediana Co., Ltd.20162—
+7K152043Diagnostic Station DS20Schiller AG20161—
+7K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—
+7K151776Central Venous Pressure SystemMespere Lifesciences, Inc.20150—
+7K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+7K140430740 SelectCas Medical Systems, Inc.20141—
+8K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+8K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+8K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+8K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+8K214115MightySat -OTCMasimo Corporation20241—
+8K231546SomfitCompumedics Limited20231—
+8K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+8K213911Microstream CO2 NanoPodCovidien, LLC20220—
+8K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+8K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+8K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+8K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+8K213463NightOwlEctosense NV20213—
+8K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+8K183559WatchPAT ONEItamar Medical, Ltd.20195—
+8K181352Loop SystemSpry Health, Inc.201910—
+8K170497V10Mediana Co., Ltd.201711
+8K170182Cardiovit FT-1Schiller AG20170—
+8K150620740 SelectCas Medical Systems, Inc.201501
+9K252383Somfit DCompumedics Limited20250—
+9K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+9K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+9K232445CSF-4 (CSF-4)Cardiacsense20240—
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+9K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+9K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+9K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+9K220351Polso WatchChronisense Medical, Ltd.20220—
+9K220095ANNE SleepSibel, Inc.20224—
+9K220028NightOwlEctosense NV20222—
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+10K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+10K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+10K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+10K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+10K232915EpiMonitorEmpatica S.r.l.20241—
+10K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+11K254042WatchPAT SWItamar Medical, Ltd.20260—
+11K250515EpiMonitorEmpatica S.r.l.20250—
+11K244027Sansa HsatHuxley Medical20252—
+12K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+12K252497Sansa HsatHuxley Medical20250—