510(k) Report

Devices descending from K013792

227 later devices reach Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+8K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbH20260—
+8K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+8K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+8K241397HinscopeHinlab Sas20240—
+8K240320Patient Monitor (RespArray)Edan Instruments, Inc.20240—
+8K232962Patient Monitor (iX10, iX12, iX15)Edan Instruments, Inc.202421
+8K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+8K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+8K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySenseBaxter Healthcare Corproration20220—
+8K222550Current Health SystemCurrent Health, Ltd.20221—
+8K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+9K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+9K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+9K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+9K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+9K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+9K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K231506Current Health SystemCurrent Health, Ltd.20230—
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K250515EpiMonitorEmpatica S.r.l.20250—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—