510(k) Report

Devices descending from K160056

4 later devices reach t:slim Insulin Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.20242—
+1K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20160—
+2K253534Pivot Insulin Delivery SystemModular Medical20261—
+3K262153Pivot Insulin Delivery SystemModular Medical, Inc.20260—