510(k) Report

Devices descending from K041524

30 later devices reach GE Datex-Ohmeda Heliox Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072926Helontix VentLinde Gas Therapeutics20080—
+1K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB200828—
+2K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+2K123149Servo-I Ventilator SystemMaquet Critical Care AB201492
+2K131774Hamilton-G5Hamilton Medical AG201310Class I
+2K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+3K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+3K180295Hamilton-G5Hamiton Medical AG20192—
+3K161450Hamilton-C3Hamilton Medical AG201732
+3K153688Edi Catheter ENFitMaquet Critical Care AB201711
+3K153046Hamilton-MR1Hamilton Medical AG20160Class I
+3K151814SERVO-U Ventilator System, SERVO-n Ventilator SystemMaquet Critical Care AB20154—
+3K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+3K103211Avea VentilatorCare Fusion20115Class I
+4K253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…Maquet Critical Care AB20260—
+4K210384Carescape R860Datex-Ohmeda, Inc.20210—
+4K201306Hamilton-C3Hamilton Medical AG20210Class I
+4K201658Hamilton-C6Hamilton Medical AG20201Class I
+4K193228Hamilton-G5Hamilton Medical AG20201—
+4K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1Maquet Critical Care AB20193—
+4K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+4K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+5K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+5K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+5K233486731 Series VentilatorZOLL Medical Corporation20240—
+5K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—
+5K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…Maquet Critical Care AB20210Class I
+5K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB20200Class I
+5K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+6K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I