510(k) Report

Devices descending from K000706

158 later devices reach Datex-Ohmeda Aestiva/5 with 7100 Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K143530Aespire ViewDatex-Ohmeda, Inc.201511
+6K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+6K123144VIVO 50Ge Healthcare, Breas Medical AB201381
+6K122715Stellar 150Resmed Germany, Inc.20130Class I
+6K123211A5 Anesthesia Delivery SystemDatascope Corp., Patient Monitoring Division201381
+6K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+6K113640Stellar 150Resmed Germany, Inc.20121—
+6K113288Vpap ST-aResmed, Ltd.20127—
+6K111473Uni-Vent (R) Model 731 Series Portable Critical Care VentilatorImpact Instrumentation, Inc.20124Class I
+6K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc.20128Class I
+6K112114Maquet Flow-I C20, Maquet Flow-I C30, Maquet Flow-I C40Maquet Critical Care AB20123Class I
+6K112914Vpap TXResmed, Ltd.20110—
+6K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+6K102182Maquet Flow-I C20, Maquet Flow-I C30, Model 66 77 200, 66 77 30Maquet Critical Care AB20114—
+6K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C201021—
+6K083688Pulmonetic Systems LTV 1200 MR Conditional VentilatorPulmonetic Systems, Inc.200921
+6K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.200837—
+7K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+7K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc.20260—
+7K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+7K233452Vivo 45 LSBreas Medical AB202501
+7K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+7K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+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—
+7K171311A5 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20180—
+7K153061Juno VPAP ST-AResmed, Ltd.20163—
+7K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+7K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+7K133958Flow-I Anesthesia System C20, C30 & C40Maquet Critical Care AB20142Class I
+7K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+7K122438Hamilton-MR1Hamilton Medical AG201311
+7K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+7K123511S9 Vpap TXResmed, Ltd.20131—
+7K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc.20126Class I
+7K122324Vpap S-aResmed, Ltd.20120—
+7K103803Hamilton-G5Hamilton Medical AG201114Class I
+7K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+8K213169BPAP SystemBMC Medical Co., Ltd.20220—
+8K170872Aisys CS2Datex-Ohmeda, Inc.201704
+8K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40Maquet Critical Care AB20171—
+8K161492Juno VPAP ST-AResmed, Ltd.20171—
+8K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+8K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+8K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+8K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+8K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+8K121225Hamilton-C2Hamilton Medical AG20128Class I
+9K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+9K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+9K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB20200Class I
+9K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+9K123637Hamilton-C3Hamilton Medical AG20124—
+10K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+10K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+11K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—