510(k) Report

Devices descending from K023264

21 later devices reach Medley Syringe Pump Module System, Model 8110 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc.20143Class I
+1K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety…Smiths Medical MD, Inc.20114Class I
+1K062699Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc.20064—
+1K053554CompufloMilestone Scientific, Inc.20066—
+2K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc.20231Class I
+2K211125Novum IQ Syringe PumpBaxter Healthcare Corporation20221Class I
+2K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo…Fresenius Kabi AG20220—
+2K191910SpaceStation MRIB. Braun Melsugen AG20200Class I
+2K172831Perfusor® Space Syringe Infusion Pump SystemB.Braun Medical, Inc.201804
+2K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20161—
+2K111381Medi-Sis Syringe Infusion SystemAcacia, Inc.20120—
+2K101194Navigator Delivery System (or Navigator DS) Model: Nav-010Carticept Medical, Inc.20115—
+2K092313Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc.200914
+3K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.20250—
+3K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation20240Class I
+3K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20160—
+3K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20114—
+4K120830Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20123—
+5K122215Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20122—
+6K124053Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20131—
+7K151255Navigator Aesthetic Delivery SystemCarticept Medical, Inc.20150—