510(k) Report

Devices descending from K974176

151 later devices reach Babylog 8000 Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies20170Class I
+6K153688Edi Catheter ENFitMaquet Critical Care AB201711
+6K160481Vivo 60Breas Medical AB201672
+6K152068Astral 100/150Resmed, Ltd.20161Class I
+6K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+6K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+6K140049Moves SLCThornhill Research, Inc.20141—
+6K121891Newport Aura VentilatorNewport Medical Instruments, Inc.20120—
+6K111610Trilogy Series Ventilator with OximetryRespironics, Inc.201111Class I
+6K103318Uni-Vent 731 Series Model Emv+ Portable Critical Care VentilatorImpact Instrumentation, Inc.201152
+6K103167Stellar 150Resmed Germany, Inc.201120—
+6K100753Flight 60 Ventilator, Model F-60Flight Medical, Ltd.20105—
+6K073694Ivent 2001 Mri ConditionalVersamed Medical Systems, Inc.20086—
+6K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG20080Class I
+6K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB200761—
+7K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+7K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+7K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+7K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+7K240807VM-2000Ventis Medical, Inc.20240—
+7K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+7K193586Vivo 45 LSBreas Medical AB20212Class I
+7K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+7K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+7K172875Astral 100/150Resmed, Ltd.20180Class I
+7K161420Moves SLCThornhill Research, Inc.20170—
+7K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+7K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+7K122715Stellar 150Resmed Germany, Inc.20130Class I
+7K113640Stellar 150Resmed Germany, Inc.20121—
+7K113288Vpap ST-aResmed, Ltd.20127—
+7K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+7K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+7K112914Vpap TXResmed, Ltd.20110—
+7K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+8K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+8K233452Vivo 45 LSBreas Medical AB202501
+8K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+8K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+8K202970Ventway SparrowInovytech Medical Solutions, Ltd.20210—
+8K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+8K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+8K153061Juno VPAP ST-AResmed, Ltd.20163—
+8K122438Hamilton-MR1Hamilton Medical AG201311
+8K123511S9 Vpap TXResmed, Ltd.20131—
+8K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+8K122324Vpap S-aResmed, Ltd.20120—
+9K213169BPAP SystemBMC Medical Co., Ltd.20220—
+9K161492Juno VPAP ST-AResmed, Ltd.20171—
+9K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+10K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—