510(k) Report

Devices descending from K914838

448 later devices reach Propaq 102,104,106,102EL,104EL,&106EL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+12K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+13K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+13K260880SedLine Sedation MonitorMasimo Corporation20260—
+13K261098TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN…Senzime AB20260—
+13K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100…Philips Medizin Systeme Boeblingen GmbH20260—
+13K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+13K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+13K250515EpiMonitorEmpatica S.r.l.20250—
+13K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+13K241397HinscopeHinlab Sas20240—
+13K231671IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470)…Philips Medizin Systeme Boeblingen GmbH20232—
+13K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+13K211619Multi-Parameter Patient MonitorShenzhen Comen Medical Instruments Co.,Ltd20220—
+13K222550Current Health SystemCurrent Health, Ltd.20221—
+13K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+13K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+13K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+14K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+14K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…Philips Medizin Systeme Böblingen GmbH20251—
+14K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+14K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+14K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+14K231506Current Health SystemCurrent Health, Ltd.20230—
+14K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+14K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+14K191882Masimo Centroid SystemMasimo Corporation20203—
+14K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+14K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+14K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+15K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+15K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+15K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+15K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+15K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+15K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+15K240251ANNE ChestSibel Health, Inc.20240—
+15K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+15K223498Radius VSM and AccessoriesMasimo Corporation202312
+15K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+15K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+15K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+15K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+15K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+15K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+16K250757Radius VSM and AccessoriesMasimo Corporation20250—
+16K231531Pediarity™Hinlab, Inc.20230—
+16K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—