510(k) Report

Devices descending from K040589

27 later devices reach Modification to Avant 9600 Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20196—
+1K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+1K120052CvinsightIntelomed, Inc.20120—
+1K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+1K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+2K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+2K222597BabySat 3Owlet Babycare, Inc.20230—
+2K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+2K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+2K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+2K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+2K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+2K131379EarlysenseEarlysense, Ltd.20137—
+3K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+3K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+3K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+3K223721Masimo StorkMasimo Corporation20230—
+3K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+3K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+3K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+3K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+3K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+4K253274BedDot (G1)Intelligent Dots, LLC20260—
+4K233827OxiWearOxiwear, Inc.20240—
+4K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+5K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+6K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—