510(k) Report

Devices descending from K223846

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231485iLet® ACE PumpBeta Bionics, Inc.202321
+2K252770iLet ACE PumpBeta Bionics, Inc.202512
+3K253976iLet ACE PumpBeta Bionics, Inc.20260—