510(k) Report

Devices descending from K231485

2 later devices reach iLet® ACE Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252770iLet ACE PumpBeta Bionics, Inc.202512
+2K253976iLet ACE PumpBeta Bionics, Inc.20260—