510(k) Report

Devices descending from K011957

134 later devices reach Ivent 201 Portable Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K180295Hamilton-G5Hamiton Medical AG20192—
+8K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…Datex-Ohmeda, Inc.20170Class I
+8K153688Edi Catheter ENFitMaquet Critical Care AB201711
+8K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+8K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+8K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+8K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20155—
+8K132530GE Datex-Ohmeda Aisys CS2 (Aisys CS^2)Datex-Ohmeda, Inc.201323
+8K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+8K122063Intellisave AX700 Anesthesia SystemPhilips Anesthesia Care20130—
+8K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc.201311Class I
+8K103211Avea VentilatorCare Fusion20115Class I
+9K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+9K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+9K210384Carescape R860Datex-Ohmeda, Inc.20210—
+9K193228Hamilton-G5Hamilton Medical AG20201—
+9K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+9K170872Aisys CS2Datex-Ohmeda, Inc.201704
+9K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+9K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+9K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+9K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+10K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+10K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+10K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+10K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+10K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+10K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+11K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+11K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+11K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+11K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+12K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—