510(k) Report

Devices descending from K020028

132 later devices reach 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091188Asahi Zenyteex Guiding CatheterAsahi Intecc Co., Ltd.20101—
+1K0712268FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043Spectranetics Corp.2007212
+1K061601Asahi Precious Guide CatheterAsahi Intecc Co., Ltd.2006109—
+2K132556Sheathless Eaucath Coronary Guide CatheterAsahi Intecc Co., Ltd.20130—
+2K093268Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20101052
+2K091299Spectranetics Turbo-Tandem SystemSpectranetics Corp.200920—
+2K072316Precious Plus Guide CatheterAsahi Intecc Co., Ltd.20070—
+3K151681IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015328
+3K150975Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2…Philips Medizin Systeme Boeblingen GmbH2015341
+3K150512STAR 90Skanray Technologies Pvt, Ltd.20151—
+3K140775Turbo-Elite Atherectomy Catheters, Turbo Tandem SystemSpectranetics Corporation2014173
+3K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013375
+3K131829Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN20130—
+3K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2013378
+3K122439Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2012414
+3K120366Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201246—
+3K113657Intellivue Patient MonitorPhilips Medizin Systeme Boblingen GmbH201281—
+3K113441Physiological Monitor, Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2012781
+3K111905Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN201136—
+3K110622Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2011902
+3K102562Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boblingen GmbH2010103—
+3K094036Turbo-Tandem System Model 472-110Spectranetics Corp.201019—
+4K210906IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot…Philips Medizin Systeme Boeblingen GmbH202162
+4K181642B-Laser Atherectomy SystemEximo Medical, Ltd.20188—
+4K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+4K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH20177—
+4K170059Spectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc.201723
+4K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+4K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation20161—
+4K153156eCareManager 4.0.1Visicu, Inc.20163—
+4K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2…Philips Medizin Systeme Boeblingen GmbH2016311
+4K152552Patient MonitorEdan Instruments, Inc.201621
+4K152181Turbo-Power Laser Atherectomy CatheterSpectranetics, Inc.201541
+4K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+4K141015Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2014361
+4K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America201410—
+4K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T…Philips Medizin Systeme Boeblingen GmbH201301
+4K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH201335—
+4K1120328FR Turbo - Tandem SystemSpectranetics Corp.20110—
+4K110474Philips Intellivue TCG10Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2011841
+5K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics20250—
+5K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—
+5K223681Respiree Cardio-Respiratory MonitorRespiree Pte, Ltd.20231—
+5K221348IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)Philips Medizin Systeme Böblingen GmbH20233—
+5K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…Edwards Lifesciences, LLC20226—
+5K220111RespiraSensePmd Solutions20221—
+5K220530Tetragraph Neuromuscular Transmission MonitorSenzime AB20221—
+5K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterNortheast Scientific, Inc.202201
+5K212047Pantheris SystemAvinger, Inc.20210—
+5K202835Auryon Atherectomy SystemEximo Medical, Ltd.20206—
+5K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+5K192137IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550Philips Medizin Systeme Boeblingen GmbH20200—
+5K182979IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient…Philips Medizin Systeme Boeblingen GmbH20195—
+5K182637Philips IntelliVue XDS SoftwarePhilips Medizin Systeme Boeblingen GmbH20190—
+5K181831IntelliVue Multi-Measurement Module MMXPhilips Medizin Systeme Boeblingen GmbH20180—
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH20186—
+5K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc.201812
+5K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20172—
+5K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH201784
+5K170876Passport Series Patient Monitors (Passport 12m, Passport 17m)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20173—
+5K171322eCareManager 4.1Visicu, Inc.20172—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+5K162561Turbo-Power (2.0mm) Laser Atherectomy CathetersSpectranetics, Inc.20173—
+5K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+5K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH201524—
+5K143195Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201491
+5K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN201420—
+6K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+6K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.20250—
+6K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.20250—
+6K233953Makani Science™ Respiration Monitoring SystemMakani Science, Inc.20250—
+6K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K230604IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)Philips Medizin Systeme Boeblingen GmbH20231—
+6K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart…Edwards Lifesciences, LLC20235—
+6K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K220116Auryon Atherectomy CathetersEximo Medical, Ltd.20224—
+6K221077Auryon Atherectomy SystemEximo Medical, Ltd.20220—
+6K211046eCareManager 4.5Visicu, Inc.20220—
+6K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+6K210160AlertWatch:ACAlertwatch, Inc.20210—
+6K191106C50 and C80 Multi-parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20191—
+6K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+6K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+6K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20181—
+6K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+6K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH201723—
+6K152902Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201661
+6K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+7K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+7K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+7K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+7K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+7K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+7K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+7K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+7K230709Auryon Atherectomy SystemEximo Medical, Ltd.20233—
+7K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+7K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy…Spectranetics, Inc.20220—
+7K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007