510(k) Report

Devices descending from K011826

11 later devices reach EPS320 Cardiac Stimulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.20260—
+1K072200StimlabMicropace Pty, Ltd.20071—
+1K071348Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd.20077—
+1K070743Z6 StimulatorSt Cardio Technologies, LLC20070—
+2K173439Bloom2 Programmable Electrophysiology StimulatorFischer Medical20180—
+2K134044EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV201451
+2K091165Horizon XvuMennen Medical, Ltd.20090—
+3K161245EP-TRACER SystemCardio Tek, BV201641
+4K183266EP-TRACER SystemSchwarzer Cardiotek GmbH201931
+5K220306ECGenius SystemCath Vision Aps20221—
+6K223787ECGenius SystemCath Vision Aps20230—