510(k) Report

Devices descending from K974332

22 later devices reach Variable Pressure Syringe Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc.200221Class I
+2K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc.20143Class I
+2K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety…Smiths Medical MD, Inc.20114Class I
+2K062699Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc.20064—
+2K053554CompufloMilestone Scientific, Inc.20066—
+3K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc.20231Class I
+3K211125Novum IQ Syringe PumpBaxter Healthcare Corporation20221Class I
+3K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo…Fresenius Kabi AG20220—
+3K191910SpaceStation MRIB. Braun Melsugen AG20200Class I
+3K172831Perfusor® Space Syringe Infusion Pump SystemB.Braun Medical, Inc.201804
+3K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20161—
+3K111381Medi-Sis Syringe Infusion SystemAcacia, Inc.20120—
+3K101194Navigator Delivery System (or Navigator DS) Model: Nav-010Carticept Medical, Inc.20115—
+3K092313Perfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc.200914
+4K243855BD Alaris Infusion System with Guardrails Suite MXCarefusion 303, Inc.20250—
+4K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation20240Class I
+4K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20160—
+4K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20114—
+5K120830Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20123—
+6K122215Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20122—
+7K124053Navigator Delivery System (Navigator DS)Carticept Medical, Inc.20131—
+8K151255Navigator Aesthetic Delivery SystemCarticept Medical, Inc.20150—