510(k) Report

Devices descending from K070513

26 later devices reach Hamilton-G5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda20113Class I
+1K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc.20096—
+1K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+2K142679Carescape R860Datex-Ohmeda, Inc.20151Class I
+2K140575Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc.20150—
+2K103211Avea VentilatorCare Fusion20115Class I
+2K102775Hamilton-C2Hamilton Medical AG201114—
+2K090468Hamilton-C2Hamilton Medical AG20090—
+3K210384Carescape R860Datex-Ohmeda, Inc.20210—
+3K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+3K131252Puritan Bennett 980 Series Ventilator SystemCovidien20142Class I
+3K121225Hamilton-C2Hamilton Medical AG20128Class I
+3K112006Hamilton-TC1Hamilton Medical AG201213—
+4K233486731 Series VentilatorZOLL Medical Corporation20240—
+4K162738Puritan Bennett 980 Ventilator SystemCovidien20171Class I
+4K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+4K123637Hamilton-C3Hamilton Medical AG20124—
+4K120574Hamilton-C1Hamilton Medical AG20123—
+4K120670Hamilton-T1Hamilton Medical AG201211Class I
+5K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC20200Class I
+5K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+5K161450Hamilton-C3Hamilton Medical AG201732
+5K153046Hamilton-MR1Hamilton Medical AG20160Class I
+6K201306Hamilton-C3Hamilton Medical AG20210Class I
+6K201658Hamilton-C6Hamilton Medical AG20201Class I
+7K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—