510(k) Report

Devices descending from K080181

21 later devices reach Modification to Galileo Gold through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103803Hamilton-G5Hamilton Medical AG201114Class I
+1K102775Hamilton-C2Hamilton Medical AG201114—
+2K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+2K131774Hamilton-G5Hamilton Medical AG201310Class I
+2K121225Hamilton-C2Hamilton Medical AG20128Class I
+2K112006Hamilton-TC1Hamilton Medical AG201213—
+3K180295Hamilton-G5Hamiton Medical AG20192—
+3K161450Hamilton-C3Hamilton Medical AG201732
+3K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+3K123637Hamilton-C3Hamilton Medical AG20124—
+3K120574Hamilton-C1Hamilton Medical AG20123—
+3K120670Hamilton-T1Hamilton Medical AG201211Class I
+4K201306Hamilton-C3Hamilton Medical AG20210Class I
+4K201658Hamilton-C6Hamilton Medical AG20201Class I
+4K193228Hamilton-G5Hamilton Medical AG20201—
+4K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+4K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+4K153046Hamilton-MR1Hamilton Medical AG20160Class I
+5K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—
+5K233486731 Series VentilatorZOLL Medical Corporation20240—
+5K231778Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, LLC20240—