510(k) Report

Devices descending from K000401

11 later devices reach Vapotherm, Model 2000I through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072845Precision FlowVapotherm, Inc.200828
+1K050314AquinoxSmiths Medical Asd, Inc.20051—
+1K042245Vapotherm Model#2000I, 200HVapotherm, Inc.20046—
+1K040862Guardian Neonate Cpap/Humidification SystemCaradyne, Ltd.200482
+1K013486Vapotherm 2000HVapotherm, Inc.20037—
+2K254078HVT 2.0Vapotherm, Inc.20260—
+2K193411O2asis Personal Oxygen HumidifierPerma Pure, LLC20200—
+2K111640Precision Flow (R) - HelioxVapotherm, Inc.201101
+2K103410Neopap SystemChildrens Medical Ventures, LLC20110—
+2K070056Vapotherm Model# 2000I and 2000HVapotherm, Inc.20070—
+2K070107Pari Hydrate GPari Innovative Manufacturers, Inc.20070—