510(k) Report

Devices descending from K042468

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+8K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+8K210384Carescape R860Datex-Ohmeda, Inc.20210—
+8K193228Hamilton-G5Hamilton Medical AG20201—
+8K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+8K170872Aisys CS2Datex-Ohmeda, Inc.201704
+8K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.201543
+8K131790A9800 Anesthesia WorkstationOricare, Inc.20140—
+8K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+8K122438Hamilton-MR1Hamilton Medical AG201311
+8K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+9K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+9K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+9K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+9K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+9K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+9K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+9K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+10K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+10K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+10K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+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—