510(k) Report

Devices descending from K971813

61 later devices reach EMBLA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162140RemLogicEmbla Systems20160—
+1K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd.201123—
+1K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+1K080427Watch-Pat Model 100S-2Itamar Medical200825—
+1K070375Earlysense ES-16 SystemEarlysense, Ltd.200723—
+1K991446Biosaca System, Model 800Biosys AB (Publ)19990—
+1K984580Biosaca SystemBiosys AB (Publ)19991—
+2K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+2K133859Watch-PAT200U (WP200U)Itamar Medical, Ltd.201422—
+2K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+2K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+2K082465EveronEarlysense, Ltd.200911—
+2K082626PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd.200921—
+2K081982Watch-Pat 200S-2 (WP200S-2)Itamar Medical200824—
+3K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+3K202464Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc.20219—
+3K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+3K161579Watch-PAT200UItamar Medical, Ltd.201720—
+3K153070Watch-PAT200UItamar Medical, Ltd.20160—
+3K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+3K092062Everon 1.0Earlysense, Ltd.201010—
+4K253274BedDot (G1)Intelligent Dots, LLC20260—
+4K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+4K234003The Circadia C200 SystemCircadia Technologies, Ltd.20242—
+4K223163Sleepiz One+Sleepiz AG20233—
+4K212143Neteera 130H/131H Vital Sign Monitoring SensorNeteera Technologies, Ltd.20221—
+4K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+4K191031NightOwlEctosense NV20205—
+4K180775Watch-PAT300Itamar Medical, Ltd.201812—
+4K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+4K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+4K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+5K254058DistaSense (TM) (v1)Life Detection Technologies20260—
+5K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—
+5K252676The Circadia C300 System (C300)Circadia Health, Inc.20261—
+5K251364Sleepiz One+ (2.5)Sleepiz AG20251—
+5K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+5K231733Neteera 130H-Plus Vital Sign Monitoring SensorNeteera Technologies, Ltd.20240—
+5K231546SomfitCompumedics Limited20231—
+5K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+5K213463NightOwlEctosense NV20213—
+5K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+5K183559WatchPAT ONEItamar Medical, Ltd.20195—
+5K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+5K131379EarlysenseEarlysense, Ltd.20137—
+6K261286The Circadia C300 System (C300)Circadia Health, Inc.20260—
+6K253388Sleepiz One+ (Model 2.5)Sleepiz AG20260—
+6K252383Somfit DCompumedics Limited20250—
+6K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+6K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—
+6K220095ANNE SleepSibel, Inc.20224—
+6K220028NightOwlEctosense NV20222—
+6K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+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—