510(k) Report

Devices descending from K902654

14 later devices reach Cdi (TM) System 100 Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K9807323M Cdi Quick-Cells with Heparin Treatment3M Healthcare19981—
+1K9734723M Cdi H/S Cuvettes with Heparon Treatment3M Healthcare19970—
+1K9729623M Cdi Blood Parameter Monitoring System 5003M Company19971026
+2K1400421.5MM Hydro Expandable Lemaitre ValvulotomeLeMaitre Vascular, Inc.201403
+2K123039Cdi Blood Parameter Monitoring System 500Terumo Cardiovascular Systems Corp.20120—
+2K110957M4 MonitorSpectrum Medical, Llp20114—
+2K090147Blood Monitoring Unit, Model Bmu 40Maquet Cardiopulmonary, AG200931
+3K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd.20183—
+3K102726Cardiohelp SystemMaquet Cardiopulmonary, AG20112Class I
+4K181942Quantum Ventilation ModuleSpectrum Medical, Ltd.20182—
+4K133598Cardiohelp SystemMaquet Cardiopulmonary, AG20140Class I
+4K133265Quadrox-IR Adult and Small AdultMaquet Cardiopulmonary, AG20130—
+5K202733Quantum Ventilation ModuleSpectrum Medical, Ltd.20201—
+6K210669Quantum Mini Ventilation ModuleSpectrum Medical, Ltd.20210—