510(k) Report

Devices descending from K060705

22 later devices reach Carina Home through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103167Stellar 150Resmed Germany, Inc.201120—
+1K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+2K113640Stellar 150Resmed Germany, Inc.20121—
+2K113288Vpap ST-aResmed, Ltd.20127—
+2K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+2K112914Vpap TXResmed, Ltd.20110—
+3K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+3K153061Juno VPAP ST-AResmed, Ltd.20163—
+3K122715Stellar 150Resmed Germany, Inc.20130Class I
+3K123511S9 Vpap TXResmed, Ltd.20131—
+3K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+3K122324Vpap S-aResmed, Ltd.20120—
+4K213169BPAP SystemBMC Medical Co., Ltd.20220—
+4K181166Trilogy EvoRespironics, Inc.20195Class I
+4K161492Juno VPAP ST-AResmed, Ltd.20171—
+4K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+5K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+5K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+5K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+5K240807VM-2000Ventis Medical, Inc.20240—
+5K193586Vivo 45 LSBreas Medical AB20212Class I
+6K233452Vivo 45 LSBreas Medical AB202501