510(k) Report

Devices descending from K974539

26 later devices reach Sullivan Vpap II ST Ventilatory Support System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053607Breas Vivo 40 SystemBreas Medical AB200625—
+2K071702Breas Vivo Bilevel System, Model Vivo 40Breas Medical AB200824—
+3K090113Breas Vivo 40 SystemBreas Medical AB200923—
+4K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd.20241—
+4K103167Stellar 150Resmed Germany, Inc.201120—
+5K242931HFT750UMekics Co., Ltd.20250—
+5K113640Stellar 150Resmed Germany, Inc.20121—
+5K113288Vpap ST-aResmed, Ltd.20127—
+5K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+5K112914Vpap TXResmed, Ltd.20110—
+6K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+6K153061Juno VPAP ST-AResmed, Ltd.20163—
+6K122715Stellar 150Resmed Germany, Inc.20130Class I
+6K123511S9 Vpap TXResmed, Ltd.20131—
+6K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+6K122324Vpap S-aResmed, Ltd.20120—
+7K213169BPAP SystemBMC Medical Co., Ltd.20220—
+7K181166Trilogy EvoRespironics, Inc.20195Class I
+7K161492Juno VPAP ST-AResmed, Ltd.20171—
+7K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+8K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+8K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+8K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+8K240807VM-2000Ventis Medical, Inc.20240—
+8K193586Vivo 45 LSBreas Medical AB20212Class I
+9K233452Vivo 45 LSBreas Medical AB202501