510(k) Report

Devices descending from K111933

49 later devices reach Covidien Nellcor Respiration Rate Software Application, Version 1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+1K242798AirmodHeroic Faith International, Ltd.20251—
+1K121806Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…Covidien201245—
+2K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLC20250—
+2K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+2K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+2K130320Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…Covidien201440—
+3K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+3K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+3K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+3K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+3K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+3K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+3K152043Diagnostic Station DS20Schiller AG20161—
+3K150272Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.201541
+3K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+3K140430740 SelectCas Medical Systems, Inc.20141—
+4K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+4K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+4K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+4K214115MightySat -OTCMasimo Corporation20241—
+4K213911Microstream CO2 NanoPodCovidien, LLC20220—
+4K213518CARESCAPE CO2 Microstream parameterCovidien, LLC20220—
+4K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+4K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+4K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+4K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+4K181352Loop SystemSpry Health, Inc.201910—
+4K170182Cardiovit FT-1Schiller AG20170—
+4K152659V10Mediana Co., Ltd.20162—
+4K150620740 SelectCas Medical Systems, Inc.201501
+5K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+5K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+5K232445CSF-4 (CSF-4)Cardiacsense20240—
+5K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+5K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+5K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+5K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+5K220351Polso WatchChronisense Medical, Ltd.20220—
+5K170497V10Mediana Co., Ltd.201711
+6K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+6K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+6K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+6K252981EmbraceMiniEmpatica S.r.l.20251—
+6K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+6K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+6K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+6K232915EpiMonitorEmpatica S.r.l.20241—
+7K250515EpiMonitorEmpatica S.r.l.20250—