510(k) Report

Devices descending from K033008

29 later devices reach Air Safety Hepa and Non-Hepa Filters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093426Bact-Trap Hepa MidiPharma Systems AB20100—
+1K072002Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG20083Class I
+1K060705Carina HomeDraeger Medical B.V.2006221
+1K050953Air Safety Model 3000/06 Filter Hepa ReusableAir Safety, Ltd.20050—
+2K132709VR Medical Heat and Moisture Exchanger and FilterVr Medical20141—
+2K103167Stellar 150Resmed Germany, Inc.201120—
+2K090738Thermoflo HCH, Thermoflo FilterArc Medical, Inc.20090—
+2K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+3K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA20220Class I
+3K113640Stellar 150Resmed Germany, Inc.20121—
+3K113288Vpap ST-aResmed, Ltd.20127—
+3K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+3K112914Vpap TXResmed, Ltd.20110—
+4K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+4K153061Juno VPAP ST-AResmed, Ltd.20163—
+4K122715Stellar 150Resmed Germany, Inc.20130Class I
+4K123511S9 Vpap TXResmed, Ltd.20131—
+4K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+4K122324Vpap S-aResmed, Ltd.20120—
+5K213169BPAP SystemBMC Medical Co., Ltd.20220—
+5K181166Trilogy EvoRespironics, Inc.20195Class I
+5K161492Juno VPAP ST-AResmed, Ltd.20171—
+5K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+6K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+6K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+6K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+6K240807VM-2000Ventis Medical, Inc.20240—
+6K193586Vivo 45 LSBreas Medical AB20212Class I
+7K233452Vivo 45 LSBreas Medical AB202501