510(k) Report

Devices descending from K011903

25 later devices reach Lifeshirt System with Vivologic Analysis Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+1K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+1K070375Earlysense ES-16 SystemEarlysense, Ltd.200723—
+2K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+2K131379EarlysenseEarlysense, Ltd.20137—
+2K082465EveronEarlysense, Ltd.200911—
+2K082626PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd.200921—
+3K202464Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc.20219—
+3K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+3K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+3K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+3K092062Everon 1.0Earlysense, Ltd.201010—
+4K253274BedDot (G1)Intelligent Dots, LLC20260—
+4K234003The Circadia C200 SystemCircadia Technologies, Ltd.20242—
+4K223163Sleepiz One+Sleepiz AG20233—
+4K212143Neteera 130H/131H Vital Sign Monitoring SensorNeteera Technologies, Ltd.20221—
+4K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+5K254058DistaSense (TM) (v1)Life Detection Technologies20260—
+5K252676The Circadia C300 System (C300)Circadia Health, Inc.20261—
+5K251364Sleepiz One+ (2.5)Sleepiz AG20251—
+5K231733Neteera 130H-Plus Vital Sign Monitoring SensorNeteera Technologies, Ltd.20240—
+5K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+6K261286The Circadia C300 System (C300)Circadia Health, Inc.20260—
+6K253388Sleepiz One+ (Model 2.5)Sleepiz AG20260—
+6K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—