510(k) Report

Devices descending from K111386

4 later devices reach Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211125Novum IQ Syringe PumpBaxter Healthcare Corporation20221Class I
+1K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20161—
+2K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation20240Class I
+2K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20160—