510(k) Report

Devices descending from K013122

33 later devices reach Ems Electrostatic Fliter and Hme Combination through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151498Breathing circuit bacterial/viral filterZhejiang Haisheng Medical Device Co., Ltd.20152—
+1K033008Air Safety Hepa and Non-Hepa FiltersAir Safety, Ltd.200429—
+2K192713Altera Filter and HME/FilterMeditera Tibbi Malzeme San VE Tic AS202011
+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—
+3K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)Passy-Muir, Inc.20230—
+3K132709VR Medical Heat and Moisture Exchanger and FilterVr Medical20141—
+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
+4K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA20220Class I
+4K113640Stellar 150Resmed Germany, Inc.20121—
+4K113288Vpap ST-aResmed, Ltd.20127—
+4K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+4K112914Vpap TXResmed, Ltd.20110—
+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—
+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—
+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