510(k) Report

Devices descending from K093788

24 later devices reach Infinity Acute Care System (Iacs) Monitoring Solution through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113798Infinity Acute Care System, Infinity Mcable- Masimo Rainbow SetDraeger Medical Systems, Inc.2012238
+2K203088Infinity Acute Care System (IACS) Monitoring SystemDraeger Medical Systems, Inc.202211
+2K201764Infinity Acute Care System (IACS) Monitoring SolutionDraeger Medical Systems, Inc.20212—
+2K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd.201918—
+2K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd.201819—
+3K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+3K192952Spire Health Remote Patient Monitoring SystemSpire, Inc. D/B/A Spire Health20200—
+3K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+4K241397HinscopeHinlab Sas20240—
+4K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+4K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+4K222550Current Health SystemCurrent Health, Ltd.20221—
+4K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+5K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+5K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+5K232915EpiMonitorEmpatica S.r.l.20241—
+5K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+5K231506Current Health SystemCurrent Health, Ltd.20230—
+6K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+6K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+6K252981EmbraceMiniEmpatica S.r.l.20251—
+6K250515EpiMonitorEmpatica S.r.l.20250—
+6K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+6K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—