510(k) Report

Devices descending from K011516

33 later devices reach Infant Flow System, Model M672P through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040862Guardian Neonate Cpap/Humidification SystemCaradyne, Ltd.200482
+1K031745Infant Flow Plus Infant Cpap System with Sipap FunctionSensor Medics Corp.200422—
+1K030563Arabella Ncpap MasksHamilton Medical AG20030—
+2K103410Neopap SystemChildrens Medical Ventures, LLC20110—
+2K062093Avea VentilatorViasys Respiratory Care, Inc.2006215
+2K042245Vapotherm Model#2000I, 200HVapotherm, Inc.20046—
+3K193411O2asis Personal Oxygen HumidifierPerma Pure, LLC20200—
+3K081521Modification to Hamilton-G5Hamilton Medical AG200816Class I
+3K072845Precision FlowVapotherm, Inc.200828
+3K072590Inspiration; Ventilator System, LS Ventilator System, Infant Ventilator System and…Event Medical, Inc.20082—
+3K070056Vapotherm Model# 2000I and 2000HVapotherm, Inc.20070—
+3K070107Pari Hydrate GPari Innovative Manufacturers, Inc.20070—
+3K063650Ventilator with Respiratory Mechanics, Model 840Puritan Bennett Corp.20070—
+4K254078HVT 2.0Vapotherm, Inc.20260—
+4K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd.20130Class I
+4K113743Evolution 3E VentilatorEvent Medical, Inc.20120—
+4K111640Precision Flow (R) - HelioxVapotherm, Inc.201101
+4K102775Hamilton-C2Hamilton Medical AG201114—
+4K090468Hamilton-C2Hamilton Medical AG20090—
+5K121225Hamilton-C2Hamilton Medical AG20128Class I
+5K112006Hamilton-TC1Hamilton Medical AG201213—
+6K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+6K123637Hamilton-C3Hamilton Medical AG20124—
+6K120574Hamilton-C1Hamilton Medical AG20123—
+6K120670Hamilton-T1Hamilton Medical AG201211Class I
+7K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+7K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+7K161450Hamilton-C3Hamilton Medical AG201732
+7K153046Hamilton-MR1Hamilton Medical AG20160Class I
+8K233486731 Series VentilatorZOLL Medical Corporation20240—
+8K201306Hamilton-C3Hamilton Medical AG20210Class I
+8K201658Hamilton-C6Hamilton Medical AG20201Class I
+9K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—