510(k) Report

Devices descending from K970866

14 later devices reach Filter Heater/Hydrator Insufflation Gas Conditioner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063546Insuflow Device, Model 6198Lexion Medical, LLC200713—
+2K162582HumiGard Surgical Humidification System, HumiGard Humdified Insufflation KitFisher & Paykel Healthcare20170—
+2K101320VasovaporLexion Medical, LLC20102—
+2K091366Insuflow DewheartLexion Medical, LLC20090—
+2K090456InsuflowLexion Medical, LLC20099—
+2K090879Insuflow CO2IONSHIELDLexion Medical, LLC20090—
+3K120640Insuflow Synergy PortLexion Medical, LLC20125—
+3K112357Vessel GuardianLexion Medical, LLC20110—
+3K102136Vessel GuardianLexion Medical, LLC20101—
+4K140263Insuflow Synergy Port, Insuflow Synergy XL PortLexion Medical, LLC20142—
+4K132203Pneuview XE Veryclear Gas Evacuation CannulaLexion Medical, LLC20130—
+4K132204Insuflow Synergy XL PortLexion Medical, LLC20133—
+5K170799AP 50/30 Insufflator with Insuflow PortLexion Medical, LLC20171—
+6K191780AP50/30 Insufflator with Insuflow PortLexion Medical, LLC20190—