510(k) Report

Devices descending from K160318

4 later devices reach PlasmaFlow through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211235CIRCUL8 Luxe DVT Prevention DeviceOrtho8, Inc.20210—
+1K211253PlasmaWaveManamed, Inc.20210—
+1K200353ManaFlowManamed, Inc.20201—
+2K240011Lymphedema CompressionJkh Health Co., Ltd.20240—