510(k) Report

Devices descending from K161469

5 later devices reach Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223607Plum Duo™ Infusion SystemIcu Medical, Inc.20232Class I
+1K183311Ivenix Infusion System (IIS)Ivenix, Inc.20191Class I
+2K242114Plum Solo™ Precision IV PumpIcu Medical, Inc.202503
+2K242115Plum Duo™ Precision IV PumpIcu Medical, Inc.202502
+2K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorIvenix, Inc.20210—