510(k) Report

Devices descending from K191679

6 later devices reach Omnipod DASH Insulin Management System with interoperable technology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234027embecta Insulin Delivery SystemEmbecta Medical I, LLC20240—
+1K230545Inessa SystemTriple Jump Israel, Ltd.20230—
+1K213134Accu-Chek Solo micropump system with interoperable technologyRoche Diabetes Care GmbH20230—
+1K203768Omnipod 5 ACE Pump (Pod)Insulet Corporation202222
+2K231826Omnipod 5 ACE PumpInsulet Corporation20231Class I
+3K260001Mint ACE PumpBeta Bionics, Inc.20260—