510(k) Report

Devices descending from K052554

112 later devices reach Modification to: Ivent 201 Portable Ventilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K233486731 Series VentilatorZOLL Medical Corporation20240—
+8K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+8K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+8K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+8K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+8K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+8K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+9K213867Carestation 750/750cDatex-Ohmeda, Inc.20230Class I
+9K201957A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202116
+9K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+9K190011Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201902
+10K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—