510(k) Report

Devices descending from K013319

124 later devices reach Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+7K220351Polso WatchChronisense Medical, Ltd.20220—
+7K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+7K220766eMurmur Heart AICsd Labs GmbH20221—
+7K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+7K191925MATRx PlusZephyr Sleep Technologies20191—
+7K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+8K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+8K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+8K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+8K252981EmbraceMiniEmpatica S.r.l.20251—
+8K252284eMurmur Heart AICsd Labs20250—
+8K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+8K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+8K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+8K243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd.20250—
+8K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+8K240901StethophoneSparrow Acoustics, Inc.20241—
+8K232915EpiMonitorEmpatica S.r.l.20241—
+8K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K200695MATRx plusZephyr Sleep Technologies20200—
+9K252595Stethophone ProSparrow Acoustics, Inc.20250—
+9K250515EpiMonitorEmpatica S.r.l.20250—