510(k) Report

Devices descending from K964204

13 later devices reach Engstrom Hmef 1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130664Hyrdromax HmefA-M Systems20130—
+1K021265Datex-Ohmeda Hmef 500Datex-Ohmeda200211—
+2K102483Sunset Healthcare Solutions Bacterial/Viral Hme Filter, Model BHF 104Sunset Healthcare Solutions, LLC20110—
+2K042891Datex-Ohmeda Oxy-Afr SensorDatex-Ohmeda20050—
+2K031653Datex-Ohmeda Hmef 750Datex-Ohmeda20034—
+2K023641Datex-Ohmeda Hmef MiniDatex-Ohmeda20027—
+3K132709VR Medical Heat and Moisture Exchanger and FilterVr Medical20141—
+3K072002Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG20083Class I
+3K030990Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorDatex-Ohmeda20036—
+4K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA20220Class I
+4K090738Thermoflo HCH, Thermoflo FilterArc Medical, Inc.20090—
+4K043120Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-FilterDatex-Ohmeda, Inc.20051—
+5K072582Provox Micron HmeAtos Medical AB20080—