510(k) Report

Devices descending from K951193

421 later devices reach Clinical Vital Signs Monitor, Model #52STP-E1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K231506Current Health SystemCurrent Health, Ltd.20230—
+9K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+9K220351Polso WatchChronisense Medical, Ltd.20220—
+9K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc.20191—
+9K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+9K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+9K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd.20140Class I
+9K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+9K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+10K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…Shanghai Draeger Medical Instrument Co., Ltd.20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.20250—
+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—
+10K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+10K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+11K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—