510(k) Report

Devices descending from K984053

13 later devices reach Becker External Drainage and Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200456Becker External Drainage and Monitoring SystemMedtronic, Inc.20201Class I
+1K171880IRRAflow CNS SystemIrras, Inc.20184—
+1K172759Smart External Drain (SED) SystemAqueduct Critical Care, Inc.20172—
+1K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc.20164—
+1K992226XDS External CSF Drainage and Monitoring SystemRadionics, Inc.20000—
+2K251598IntellidropBrainspace, Inc.20250—
+2K243676Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery20250—
+2K200807IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Inc.20202—
+2K192289IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control UnitIrras USA, Ltd.20193—
+2K181301Smart External Drain (SED) SystemAqueduct Critical Care, Inc.20180—
+2K171586Smart External Drain (SED) SystemAqueduct Critical Care, Inc.20173—
+3K222471IRRAflow Active Fluid Exchange System (AFES)Irras USA20221—
+4K231664IRRAflow Active Fluid Exchange System (AFES)Irras USA, Inc.20230—