510(k) Report

Devices descending from K042039

53 later devices reach Family of Crystal 20 Monitors Model #CS20-600,900,1300,1400,2400 & 120 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073682Embletta GoldEmbla Systems, Inc.2008411
+1K063872KinesiaCleveland Medical Devices, Inc.200710—
+2K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20149—
+2K122516Embletta MPREmbla Systems2013271
+2K092003CPC Sleep Data Recorder, Model M1, and Application SoftwareMyCardio, LLC20094—
+2K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+3K213519Rune Labs Tremor Transducer SystemRune Labs, Inc.20224—
+3K210593Onera Sleep Test System (Onera STS)Onera B.V.20223—
+3K203343Wesper LabWesper, Inc.20211—
+3K163696SleepImage SystemMycardio, LLC Dba Sleepimage.20173—
+3K161579Watch-PAT200UItamar Medical, Ltd.201720—
+3K161717Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20163—
+3K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+3K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+3K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+4K260050WRAP SystemHuneo, LLC20260—
+4K253055Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)Nordic Kinetics AB20260—
+4K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+4K223573Onera Sleep Test System (Onera STS)Onera B.V.20231—
+4K221772NeuroRPMNew Touch Digital, Inc.20230—
+4K221816Wesper LabWesper, Inc.20230—
+4K220820Parky AppH2o Bilisim Yazilim20223—
+4K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+4K211887Personal Kinetigraph (PKG) System Gen 2 PlusGkc Manufacturing Pty, Ltd.20221—
+4K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+4K191031NightOwlEctosense NV20205—
+4K182618SleepImage SystemMycardio, LLC Dba Sleepimage.20192—
+4K180775Watch-PAT300Itamar Medical, Ltd.201812—
+5K262515Kneu Platform (V2)Kneu Health Digital, Ltd.20260—
+5K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+5K252628CassieWesper, Inc.20260—
+5K243220Onera STS 2 (ONERA STS 2)Onera B.V.20250—
+5K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+5K250153Neu PlatformNeuhealth Digital, Ltd.20251—
+5K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+5K231355AuroraEnsodata20240—
+5K231546SomfitCompumedics Limited20231—
+5K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+5K213463NightOwlEctosense NV20213—
+5K183559WatchPAT ONEItamar Medical, Ltd.20195—
+6K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+6K252383Somfit DCompumedics Limited20250—
+6K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+6K220095ANNE SleepSibel, Inc.20224—
+6K220028NightOwlEctosense NV20222—
+7K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+7K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+7K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+7K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+8K254042WatchPAT SWItamar Medical, Ltd.20260—
+8K244027Sansa HsatHuxley Medical20252—
+9K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+9K252497Sansa HsatHuxley Medical20250—