510(k) Report

Devices descending from K131223

13 later devices reach Carescape Monitor B650 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191249Carescape B450GE Healthcare Finland Oy20204—
+1K191149Carescape B650GE Healthcare Finland Oy202072
+2K213181CARESCAPE B650, E-musbGE Healthcare Finland Oy202262
+2K213363CARESCAPE B450, E-musbGE Healthcare Finland Oy202211
+2K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+3K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+3K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+3K230579Smart Wedge algorithmEdwards Lifesciences, LLC20235—
+4K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences20244—
+5K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)Edwards Lifesciences20250—
+5K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences202521
+6K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+6K253034HemoSphere Stream ModuleEdwards Lifesciences20250—