510(k) Report

Devices descending from K984407

115 later devices reach Bipap Harmony S/T, Model 1001445 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda201332
+8K233486731 Series VentilatorZOLL Medical Corporation20240—
+8K201306Hamilton-C3Hamilton Medical AG20210Class I
+8K201658Hamilton-C6Hamilton Medical AG20201Class I
+8K193228Hamilton-G5Hamilton Medical AG20201—
+8K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20183—
+8K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+8K151570Carestation 620/650/650CDatex-Ohmeda, Inc.20161Class I
+9K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+9K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+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—