510(k) Report

Devices descending from K934475

7 later devices reach Koko Filter II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121382Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]Westmed, Inc.20120—
+1K083233The PFT FilterPulmonary Filtration Technologies, LLC20090—
+1K062913Astraguard Pulmonary Function FilterSdi Diagnostics, Inc.20070—
+1K043148All Flow Pulmonary Function FilterAlliance Tech Medical, Inc.200421
+1K013123Ems Pulmonary Function Testing FilterEngineered Medical Systems20023—
+2K051712Model 2800 PFT FilterAir Safety, Ltd.20051—
+3K142303NeumoFilt Ergo/Neumo Filt BiteOnMedical Respiratory Devices S.L.20140—