510(k) Report

Devices descending from K050312

11 later devices reach Amigo Insulin Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071613Amigo Insulin PumpNipro Diabetes Systems, Inc.200710—
+2K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc.20119Class I
+3K141758T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc.20147—
+3K133593T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc.20148—
+4K160056t:slim Insulin Delivery SystemTandem Diabetes Care, Inc.20164—
+4K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20161—
+4K143189t:flex Insulin Delivery SystemTandem Diabetes Care, Inc.20152—
+5K240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.20242—
+5K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20160—
+6K253534Pivot Insulin Delivery SystemModular Medical20261—
+7K262153Pivot Insulin Delivery SystemModular Medical, Inc.20260—