510(k) Report

Devices descending from K031487

42 later devices reach Model Avant 2120 Pulse Oximeter and Nibp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc.20097—
+1K053209Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement SystemSuntech Medical, Inc.200613—
+1K040589Modification to Avant 9600 Pulse OximeterNonin Medical, Inc.200427—
+2K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20196—
+2K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+2K172586Vios Monitoring System™ Model 2050Vios Medical, Inc.201824
+2K132402Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc.201431
+2K122401Tango M2 Blood Pressure MonitorSuntech Medical, Inc.20120—
+2K120052CvinsightIntelomed, Inc.20120—
+2K120465Earlysense (Everon) SystemEarlysense, Ltd.20129—
+2K071642Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse OximeterMediaid, Inc.20080—
+2K063814BP-200 PlusSchiller AG20077—
+2K060820Cycle BP Monitor and Pulse Oximeter, Model 1060Suntech Medical, Inc.20062—
+3K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)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—
+3K222597BabySat 3Owlet Babycare, Inc.20230—
+3K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+3K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc.20200—
+3K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20194—
+3K160865Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series…Nonin Medical, Inc.20161—
+3K152043Diagnostic Station DS20Schiller AG20161—
+3K152831Spot SkanSkanray Technologies Private Limited20160—
+3K151512Star 60Skanray Technologies Private Limited20160—
+3K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd.20146—
+3K131379EarlysenseEarlysense, Ltd.20137—
+3K101619Welch Allyn 1500 Patient MonitorSchiller AG20104—
+4K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+4K233827OxiWearOxiwear, Inc.20240—
+4K223721Masimo StorkMasimo Corporation20230—
+4K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co., Ltd.20190—
+4K171836EarlySense Bed Sensing UnitEarlysense, Ltd.20180—
+4K170182Cardiovit FT-1Schiller AG20170—
+4K152911EarlySense Insight SytemEarlysense, Ltd.20165—
+4K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+5K253274BedDot (G1)Intelligent Dots, LLC20260—
+5K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+6K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+7K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—
+7K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007