510(k) Report

Devices descending from K002201

44 later devices reach Electrostatic Hydrophobic Breathing Filter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033008Air Safety Hepa and Non-Hepa FiltersAir Safety, Ltd.200429—
+1K013122Ems Electrostatic Fliter and Hme CombinationEngineered Medical Systems200233—
+1K013089Ems Hepa Filter and Hme CombinationsEngineered Medical Systems200239—
+2K151498Breathing circuit bacterial/viral filterZhejiang Haisheng Medical Device Co., Ltd.20152—
+2K132709VR Medical Heat and Moisture Exchanger and FilterVr Medical20141—
+2K093426Bact-Trap Hepa MidiPharma Systems AB20100—
+2K072002Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG20083Class I
+2K060705Carina HomeDraeger Medical B.V.2006221
+2K050953Air Safety Model 3000/06 Filter Hepa ReusableAir Safety, Ltd.20050—
+2K040712Air Safety Hepa, Model 3500Air Safety, Ltd.20040—
+2K021265Datex-Ohmeda Hmef 500Datex-Ohmeda200211—
+3K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA20220Class I
+3K192713Altera Filter and HME/FilterMeditera Tibbi Malzeme San VE Tic AS202011
+3K102483Sunset Healthcare Solutions Bacterial/Viral Hme Filter, Model BHF 104Sunset Healthcare Solutions, LLC20110—
+3K103167Stellar 150Resmed Germany, Inc.201120—
+3K090738Thermoflo HCH, Thermoflo FilterArc Medical, Inc.20090—
+3K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+3K042891Datex-Ohmeda Oxy-Afr SensorDatex-Ohmeda20050—
+3K031653Datex-Ohmeda Hmef 750Datex-Ohmeda20034—
+3K023641Datex-Ohmeda Hmef MiniDatex-Ohmeda20027—
+4K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc.20230—
+4K113640Stellar 150Resmed Germany, Inc.20121—
+4K113288Vpap ST-aResmed, Ltd.20127—
+4K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+4K112914Vpap TXResmed, Ltd.20110—
+4K030990Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorDatex-Ohmeda20036—
+5K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+5K153061Juno VPAP ST-AResmed, Ltd.20163—
+5K122715Stellar 150Resmed Germany, Inc.20130Class I
+5K123511S9 Vpap TXResmed, Ltd.20131—
+5K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+5K122324Vpap S-aResmed, Ltd.20120—
+5K043120Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-FilterDatex-Ohmeda, Inc.20051—
+6K213169BPAP SystemBMC Medical Co., Ltd.20220—
+6K181166Trilogy EvoRespironics, Inc.20195Class I
+6K161492Juno VPAP ST-AResmed, Ltd.20171—
+6K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+6K072582Provox Micron HmeAtos Medical AB20080—
+7K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+7K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+7K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+7K240807VM-2000Ventis Medical, Inc.20240—
+7K193586Vivo 45 LSBreas Medical AB20212Class I
+8K233452Vivo 45 LSBreas Medical AB202501