510(k) Report

Devices descending from K040490

97 later devices reach Welch Allyn Spot Ultra Vital Signs Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+1K101680Welch Allyn Spot Vital Signs Lxi Model 45000 SeriesWelch Allyn, Inc.2010332
+1K101445Vital Signs Monitor-VSM 6000 SeriesWelch Allyn, Inc.201073—
+1K093907Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceWelch Allyn, Inc.201074—
+1K071642Mediaid M960 Series, Vital Signs Monitor and Mediaid M900 Series, Pulse OximeterMediaid, Inc.20080—
+2K161909IQvitals ZoneMidmark Corporation201614
+2K160439SunTech CT40 Spot-check Vital Signs DeviceSuntech Medical20161—
+2K152831Spot SkanSkanray Technologies Private Limited20160—
+2K151512Star 60Skanray Technologies Private Limited20160—
+2K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+2K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+2K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+2K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+2K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201167—
+2K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+3K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+3K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+3K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+3K192092Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535Seca GmbH & Co. KG20200—
+3K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+3K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+3K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+3K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+3K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201166—
+4K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+4K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+4K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+4K191882Masimo Centroid SystemMasimo Corporation20203—
+4K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+4K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+4K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+4K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+4K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+4K133484Zoll X SeriesZoll Medical Corp20141—
+4K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+4K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc.201265—
+4K121367Zoll Propaq XMZOLL Medical Corporation201231
+5K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+5K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+5K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+5K240251ANNE ChestSibel Health, Inc.20240—
+5K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+5K223498Radius VSM and AccessoriesMasimo Corporation202312
+5K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+5K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+5K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+5K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+5K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+5K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+5K180482ZOLL Propaq MZOLL Medical Corporation20182—
+5K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc.201723
+5K142915ZOLL X SeriesZOLL Medical Corporation20140—
+5K141774Zoll X SeriesZOLL Medical Corporation20142—
+5K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+5K132808Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc.20136—
+6K250757Radius VSM and AccessoriesMasimo Corporation20250—
+6K231531Pediarity™Hinlab, Inc.20230—
+6K212473Welch Allyn Connex Central StationWelch Allyn, Inc.20220—
+6K202375ZOLL Propaq MZOLL Medical Corporation20211—
+6K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+6K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—
+6K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+6K172890SedLine Sedation MonitorMasimo Corporation20185—
+6K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc.201413
+6K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+7K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+7K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+7K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+7K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+7K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+8K260880SedLine Sedation MonitorMasimo Corporation20260—
+8K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+8K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+8K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+9K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+9K214115MightySat -OTCMasimo Corporation20241—
+9K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+9K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+9K211632Pulse 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—
+9K181352Loop SystemSpry Health, Inc.201910—
+10K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+10K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+10K232445CSF-4 (CSF-4)Cardiacsense20240—
+10K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+10K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+10K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+10K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+10K220351Polso WatchChronisense Medical, Ltd.20220—
+11K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+11K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+11K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+11K252981EmbraceMiniEmpatica S.r.l.20251—
+11K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+11K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+11K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+11K232915EpiMonitorEmpatica S.r.l.20241—
+12K250515EpiMonitorEmpatica S.r.l.20250—