510(k) Report

Devices descending from K132547

8 later devices reach Endo Tool Glucose Management System (Egms) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200443EndoTool IV 1.10Monarch Medical Technologies, LLC20203—
+1K160673Insulin Algorithms SystemInsulin Algorithms20170—
+1K142918EndoTool SubQMonarch Medical Technologies20152—
+2K201619EndoTool IV SystemMonarch Medical Technologies, LLC20202—
+2K180366EndoTool SubQAl Pacheco and Associates20181—
+3K241088EndoTool IV (3.1)Monarch Medical Technologies20241—
+3K211160EndoTool SubQ 2.1Monarch Medical Technologies, LLC20210—
+4K260910EndoTool IV Cloud 1.0Glooko, Inc.20260—