510(k) Report

Devices descending from K071613

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

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