510(k) Report

Devices descending from K073682

41 later devices reach Embletta Gold through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122516Embletta MPREmbla Systems2013271
+1K092003CPC Sleep Data Recorder, Model M1, and Application SoftwareMyCardio, LLC20094—
+1K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+2K210593Onera Sleep Test System (Onera STS)Onera B.V.20223—
+2K203343Wesper LabWesper, Inc.20211—
+2K163696SleepImage SystemMycardio, LLC Dba Sleepimage.20173—
+2K161579Watch-PAT200UItamar Medical, Ltd.201720—
+2K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+2K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+2K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+3K260050WRAP SystemHuneo, LLC20260—
+3K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+3K223573Onera Sleep Test System (Onera STS)Onera B.V.20231—
+3K221816Wesper LabWesper, Inc.20230—
+3K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+3K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+3K191031NightOwlEctosense NV20205—
+3K182618SleepImage SystemMycardio, LLC Dba Sleepimage.20192—
+3K180775Watch-PAT300Itamar Medical, Ltd.201812—
+4K252628CassieWesper, Inc.20260—
+4K243220Onera STS 2 (ONERA STS 2)Onera B.V.20250—
+4K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+4K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+4K231355AuroraEnsodata20240—
+4K231546SomfitCompumedics Limited20231—
+4K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+4K213463NightOwlEctosense NV20213—
+4K183559WatchPAT ONEItamar Medical, Ltd.20195—
+5K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+5K252383Somfit DCompumedics Limited20250—
+5K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+5K220095ANNE SleepSibel, Inc.20224—
+5K220028NightOwlEctosense NV20222—
+6K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+6K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+6K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+6K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+7K254042WatchPAT SWItamar Medical, Ltd.20260—
+7K244027Sansa HsatHuxley Medical20252—
+8K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+8K252497Sansa HsatHuxley Medical20250—