510(k) Report

Devices descending from K031745

22 later devices reach Infant Flow Plus Infant Cpap System with Sipap Function through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062093Avea VentilatorViasys Respiratory Care, Inc.2006215
+2K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+2K072590Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and…Event Medical, Inc.20082—
+2K063650Ventilator with Respiratory Mechanics, Model 840Puritan Bennett Corp.20070—
+3K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+3K113743Evolution 3E VentilatorEvent Medical, Inc.20120—
+3K102775Hamilton-C2Hamilton Medical AG201114—
+3K090468Hamilton-C2Hamilton Medical AG20090—
+4K121225Hamilton-C2Hamilton Medical AG20128Class I
+4K112006Hamilton-TC1Hamilton Medical AG201213—
+5K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+5K123637Hamilton-C3Hamilton Medical AG20124—
+5K120574Hamilton-C1Hamilton Medical AG20123—
+5K120670Hamilton-T1Hamilton Medical AG201211Class I
+6K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+6K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+6K161450Hamilton-C3Hamilton Medical AG201732
+6K153046Hamilton-MR1Hamilton Medical AG20160Class I
+7K233486731 Series VentilatorZOLL Medical Corporation20240—
+7K201306Hamilton-C3Hamilton Medical AG20210Class I
+7K201658Hamilton-C6Hamilton Medical AG20201Class I
+8K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—