510(k) Report

Devices descending from K053563

7 later devices reach Humapen Memoir through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093065Finesse Personal Insulin Delivery Patch, Model FG-2000Calibra Medical, Inc.20106—
+2K243273CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA20241—
+2K111924Finesse Personal Insulin Delivery PatchCalibra Medical, Inc.20124—
+2K100947Finesse Personal Insulin Delivery Patch, Model FG 2000Calibra Medical, Inc.20105—
+3K252757CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA20260—
+3K233447CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA20242—
+3K163357OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division of Cilag GmbH20173—