510(k) Report

Devices descending from K982992

65 later devices reach Zoll M Series SPO2 Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042007Zoll E Series DefibrillatorZoll Medical Corp2005643
+2K110168Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters201115—
+2K091265Zoll E Series with CprreadychargeZoll Medical Corporation, World Wide Headquarters20090—
+2K092598Zoll E Series with Spco/Spmet OptionZoll Medical Corporation, World Wide Headquarters20092—
+2K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp200927—
+2K090801Electronic House CallExpress MD Solutions, LLC20093—
+2K081081Zoll E Series with Bluetooth Dial UP NetworkingZoll Medical Corporation, World Wide Headquarters20090—
+2K080903Zoll E Series with Intibation Assist OptionZOLL Medical Corporation20083—
+2K080232Zoll E Series 12SL, Analysis OptionZoll Medical Corporation, World Wide Headquarters20080—
+2K060559Zoll R Series DefibrillatorZOLL Medical Corporation2006211
+3K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+3K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+3K140502Zoll E Series AlsZOLL Medical Corporation20141—
+3K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+3K122839Zoll Surepower Single Bay ChargerZOLL Medical Corporation20120—
+3K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+3K102063Health-E-Connect SystemAlr Technologies20111—
+3K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters201110—
+3K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation201191
+3K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+3K093895Ally Platform SystemContinuity Health Solutions20100—
+3K081828Zoll R Series BLS DefibrillatorZOLL Medical Corporation20088—
+3K081574Zoll R SeriesZOLL Medical Corporation20088—
+4K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+4K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+4K163664Health-e-Connect System with IDAAlr Technologies20170—
+4K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+4K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.20150—
+4K133239Zoll E SeriesZoll Medical Corporation, World Wide Headquarters20150—
+4K133441Onestep CPR II Multi-Function ElectrodeBio-Detek, Inc.20141—
+4K133484Zoll X SeriesZoll Medical Corp20141—
+4K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+4K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters20126—
+4K121367Zoll Propaq XMZOLL Medical Corporation201231
+4K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+4K110361Zoll R Series with 2010 Aha Guidelines Software UpdateZoll Medical Corporation, World Wide Headquarters20117—
+4K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+5K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+5K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+5K191882Masimo Centroid SystemMasimo Corporation20203—
+5K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+5K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+5K180482ZOLL Propaq MZOLL Medical Corporation20182—
+5K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+5K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc.20150—
+5K142915ZOLL X SeriesZOLL Medical Corporation20140—
+5K141774Zoll X SeriesZOLL Medical Corporation20142—
+6K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+6K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+6K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+6K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+6K240251ANNE ChestSibel Health, Inc.20240—
+6K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+6K223498Radius VSM and AccessoriesMasimo Corporation202312
+6K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+6K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+6K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+6K202375ZOLL Propaq MZOLL Medical Corporation20211—
+6K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+6K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+6K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+7K250757Radius VSM and AccessoriesMasimo Corporation20250—
+7K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+7K231531Pediarity™Hinlab, Inc.20230—
+7K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—