510(k) Report

Devices descending from K220916

2 later devices reach iLet® Dosing Decision Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232224iLet® Dosing Decision SoftwareBeta Bionics, Inc.202311
+2K262763iLet Dosing Decision SoftwareBeta Bionics, Inc.20260—