510(k) Report

Devices descending from K894053

14 later devices reach 2ND Modification of Fef (TM) End-Tidal CO2 Detector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042572Kendall CO2NFIRM Now CO2 DetectorKendall20041—
+1K021576Mercury Medical STATCO2 End Tidal CO2 Detector, Model 10-55370Mercury Medical20024—
+1K991955Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…Engineered Medical Systems19990—
+1K991953Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…Engineered Medical Systems19990—
+1K960468DMR/CO2 Combo KtiNellcor Puritan Bennett, Inc.19966—
+2K212316DoubleChek DC-1001Nasogastric Feeding Solutions, Ltd.20220—
+2K133540FlocapMaxtec, Inc.20141—
+2K112840Capnodura Combi & Capnodura Pedi CO2 DetectorSeebreath AB20120—
+2K031814STATCO2METER, Model 10-55372Mercury Medical20030—
+2K973419DMR Plus Disposable Manual ResuscitatorNellcor Puritan Bennett, Inc.19985—
+3K261633VisuBreathAffirm Medical Technologies II, LLC20260—
+3K021328Smart Bag MOO-Two Systems International, Inc.20031—
+3K023494Nellcor Indgo Manual ResuscitatorNellcor Puritan Bennett, Inc.20030—
+4K212905Sotair DeviceSafe Bvm Corporation20220—