510(k) Report

Devices descending from K053607

25 later devices reach Breas Vivo 40 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071702Breas Vivo Bilevel System, Model Vivo 40Breas Medical AB200824—
+2K090113Breas Vivo 40 SystemBreas Medical AB200923—
+3K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+3K103167Stellar 150Resmed Germany, Inc.201120—
+4K242931HFT750UMekics Co., Ltd.20250—
+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