510(k) Report

Devices descending from K022732

75 later devices reach Infant/Child Reduced Energy Electrodes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120536Heart Sync Pediatric Physio Aed PadHeart Sync, Inc.20120—
+1K040479Pediatric Energy Reducer, Models Aed-10 and Aed-20Welch Allyn, Inc.20040—
+1K033474Zoll Aed PlusZoll Medical Corp2004721
+2K110978Onestep Pediatric Mfe'sZOLL Medical Corporation20117—
+2K110154Zoll Aed Plus with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters20112—
+2K091561Zoll Aed Plus Version 5.32 Software ReleaseZOLL Medical Corporation20100—
+2K042007Zoll E Series DefibrillatorZoll Medical Corp2005643
+2K041892Zoll Aed Pro External DefibrillatorZOLL Medical Corporation200523—
+3K120406Zoll Fully Automatic Aed PlusZoll Medical Corporation, World Wide Headquarters20121—
+3K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters20126—
+3K110526Zoll Aedpro with 2010 Aha Guidelines Software UpdateZOLL Medical Corporation20110—
+3K110168Zoll E Series with 2010 Aha Guidlines Software UpdateZoll Medical Corporation, World Wide Headquarters201115—
+3K091265Zoll E Series with CprreadychargeZoll Medical Corporation, World Wide Headquarters20090—
+3K092598Zoll E Series with Spco/Spmet OptionZoll Medical Corporation, World Wide Headquarters20092—
+3K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp200927—
+3K090801Electronic House CallExpress MD Solutions, LLC20093—
+3K081081Zoll E Series with Bluetooth Dial UP NetworkingZoll Medical Corporation, World Wide Headquarters20090—
+3K080903Zoll E Series with Intibation Assist OptionZOLL Medical Corporation20083—
+3K080232Zoll E Series 12SL, Analysis OptionZoll Medical Corporation, World Wide Headquarters20080—
+3K060559Zoll R Series DefibrillatorZOLL Medical Corporation2006211
+4K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+4K143714Powerheart G5 AEDCardiac Science Corporation20150—
+4K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc.20150—
+4K133659Heartstart XL+Defibrillator/Monitor with End-Tidal Carbon Dioxide MonitoringPhilips Medical Systems20151—
+4K140502Zoll E Series AlsZOLL Medical Corporation20141—
+4K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters20144—
+4K130153Hearstart MRX with Airway Confimration AssistPhilips Medical Systems20132—
+4K122839Zoll Surepower Single Bay ChargerZOLL Medical Corporation20120—
+4K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters201282
+4K102063Health-E-Connect SystemAlr Technologies20111—
+4K111594Zoll E SeriesZoll Medical Corporation, World Wide Headquarters201110—
+4K110742Onestep Adult Multi-Function ElectrodeZOLL Medical Corporation201191
+4K100654Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201011—
+4K093895Ally Platform SystemContinuity Health Solutions20100—
+4K081828Zoll R Series BLS DefibrillatorZOLL Medical Corporation20088—
+4K081574Zoll R SeriesZOLL Medical Corporation20088—
+5K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company202004
+5K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+5K163664Health-e-Connect System with IDAAlr Technologies20170—
+5K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+5K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.20150—
+5K133239Zoll E SeriesZoll Medical Corporation, World Wide Headquarters20150—
+5K142915ZOLL X SeriesZOLL Medical Corporation20140—
+5K141774Zoll X SeriesZOLL Medical Corporation20142—
+5K133441Onestep CPR II Multi-Function ElectrodeBio-Detek, Inc.20141—
+5K133484Zoll X SeriesZoll Medical Corp20141—
+5K121367Zoll Propaq XMZOLL Medical Corporation201231
+5K112761Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters201201
+5K110361Zoll R Series with 2010 Aha Guidelines Software UpdateZoll Medical Corporation, World Wide Headquarters20117—
+5K102468Zoll Propaq MDZoll Medical Corporation, World Wide Headquarters20109—
+6K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+6K202375ZOLL Propaq MZOLL Medical Corporation20211—
+6K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+6K191882Masimo Centroid SystemMasimo Corporation20203—
+6K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+6K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+6K180482ZOLL Propaq MZOLL Medical Corporation20182—
+6K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+7K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+7K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+7K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+7K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+7K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—
+7K240251ANNE ChestSibel Health, Inc.20240—
+7K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+7K223498Radius VSM and AccessoriesMasimo Corporation202312
+7K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+7K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+7K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+7K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+7K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+7K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+8K250757Radius VSM and AccessoriesMasimo Corporation20250—
+8K231531Pediarity™Hinlab, Inc.20230—
+8K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—