510(k) Report

Devices descending from K003004

146 later devices reach Oscar 2, Model 222 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K192624ApneaTrakCadwell Industries, Inc.20200—
+7K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+7K171304Maxxi Rip SensorNeurovirtual USA, Inc.20190—
+7K181988eMurmur IDCsd Labs GmbH20197—
+7K181352Loop SystemSpry Health, Inc.201910—
+7K181996MATRx PlusZephyr Sleep Technologies20182—
+7K181503Fingertip Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20186—
+7K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…Hill-Rom, Inc.20182—
+7K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+7K152091Fingertip Pulse OximeterJiangsu Konsung Bio-Medical Science & Technology Co., Ltd.20160—
+7K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—
+8K250837Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20250—
+8K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+8K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+8K232975Pulse Oximeter (MD300C228)Beijing Choice Electronic Technology Co., Ltd.20240—
+8K232445CSF-4 (CSF-4)Cardiacsense20240—
+8K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+8K230172Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20231—
+8K230823AusculThing ACCAusculthing OY20230—
+8K220101Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20230—
+8K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+8K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+8K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+8K220351Polso WatchChronisense Medical, Ltd.20220—
+8K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+8K220766eMurmur Heart AICsd Labs GmbH20221—
+8K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and…Hill-Rom, Inc.20211—
+8K191925MATRx PlusZephyr Sleep Technologies20191—
+8K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+9K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K252284eMurmur Heart AICsd Labs20250—
+9K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+9K243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd.20250—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+9K240901StethophoneSparrow Acoustics, Inc.20241—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+9K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—
+9K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+9K200695MATRx plusZephyr Sleep Technologies20200—
+10K252595Stethophone ProSparrow Acoustics, Inc.20250—
+10K250515EpiMonitorEmpatica S.r.l.20250—