510(k) Report

Devices descending from K902859

235 later devices reach Servo Ventilator 300 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+6K151120Simple T Pediatric Nasal MaskRespironics, Inc.20160—
+6K153061Juno VPAP ST-AResmed, Ltd.20163—
+6K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+6K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+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—
+6K120562Performax Pediatric EE Total Face MaskRespironics, Inc.20120—
+6K120639Performax Pediatric SE Total Face MaskRespironics, Inc.20120—
+6K120574Hamilton-C1Hamilton Medical AG20123—
+6K120670Hamilton-T1Hamilton Medical AG201211Class I
+6K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+6K100528Breathe Technologies Ventilator and Accessories BT-V2SBreathe Technologies, Inc.20104—
+6K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+7K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+7K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+7K233452Vivo 45 LSBreas Medical AB202501
+7K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+7K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+7K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+7K213169BPAP SystemBMC Medical Co., Ltd.20220—
+7K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+7K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+7K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+7K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+7K161492Juno VPAP ST-AResmed, Ltd.20171—
+7K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+7K122438Hamilton-MR1Hamilton Medical AG201311
+7K102525Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20103—
+8K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+8K103345Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20112—
+9K131562Breathe Niov Ventilation SystemBreathe Technologies20141—
+10K152664TAV SystemNew Aera, Inc.20160—