510(k) Report

Devices descending from K001020

270 later devices reach 8100 Vital Signs Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+10K260880SedLine Sedation MonitorMasimo Corporation20260—
+10K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+10K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+10K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+10K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+10K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+10K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+10K241397HinscopeHinlab Sas20240—
+10K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+10K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+10K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+10K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+10K222550Current Health SystemCurrent Health, Ltd.20221—
+10K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+10K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+10K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+10K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+11K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+11K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+11K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+11K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+11K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+11K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+11K232915EpiMonitorEmpatica S.r.l.20241—
+11K214115MightySat -OTCMasimo Corporation20241—
+11K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+11K231506Current Health SystemCurrent Health, Ltd.20230—
+11K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+11K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+11K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+11K211632Pulse 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—
+11K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+11K191882Masimo Centroid SystemMasimo Corporation20203—
+11K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+11K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+11K181352Loop SystemSpry Health, Inc.201910—
+11K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+12K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+12K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+12K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+12K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+12K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+12K252981EmbraceMiniEmpatica S.r.l.20251—
+12K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+12K250515EpiMonitorEmpatica S.r.l.20250—
+12K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+12K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+12K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+12K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+12K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+12K240251ANNE ChestSibel Health, Inc.20240—
+12K232445CSF-4 (CSF-4)Cardiacsense20240—
+12K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+12K223498Radius VSM and AccessoriesMasimo Corporation202312
+12K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+12K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+12K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+12K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+12K220351Polso WatchChronisense Medical, Ltd.20220—
+12K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+12K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+12K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+12K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+13K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+13K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+13K250757Radius VSM and AccessoriesMasimo Corporation20250—
+13K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+13K231531Pediarity™Hinlab, Inc.20230—
+13K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—