510(k) Report

Devices descending from K915488

135 later devices reach Pediatric Ventilator and Partner Volume Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+8K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.201113Class I
+8K103803Hamilton-G5Hamilton Medical AG201114Class I
+8K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+8K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20119Class I
+9K213169BPAP SystemBMC Medical Co., Ltd.20220—
+9K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+9K161492Juno VPAP ST-AResmed, Ltd.20171—
+9K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+9K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+9K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+9K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+9K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+9K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+9K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+9K121225Hamilton-C2Hamilton Medical AG20128Class I
+10K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—
+10K170872Aisys CS2Datex-Ohmeda, Inc.201704
+10K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+10K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+10K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+10K123637Hamilton-C3Hamilton Medical AG20124—
+11K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+11K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+12K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+12K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+12K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+13K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—