510(k) Report

Devices descending from K161605

4 later devices reach Smart External Drain (SED) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171586Smart External Drain (SED) SystemAqueduct Critical Care, Inc.20173—
+2K172759Smart External Drain (SED) SystemAqueduct Critical Care, Inc.20172—
+3K251598IntellidropBrainspace, Inc.20250—
+3K181301Smart External Drain (SED) SystemAqueduct Critical Care, Inc.20180—