510(k) Report

Devices descending from K083517

125 later devices reach Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+6K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+6K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+6K241397HinscopeHinlab Sas20240—
+6K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+6K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+6K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+6K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+6K222550Current Health SystemCurrent Health, Ltd.20221—
+6K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+7K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+7K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+7K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+7K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+7K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+7K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+7K232915EpiMonitorEmpatica S.r.l.20241—
+7K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+7K231506Current Health SystemCurrent Health, Ltd.20230—
+8K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+8K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+8K252981EmbraceMiniEmpatica S.r.l.20251—
+8K250515EpiMonitorEmpatica S.r.l.20250—
+8K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+8K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—