510(k) Report

Devices descending from K082520

11 later devices reach Sealguard Evac Endotracheal and Endotracheal Tubes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093126Anapnoguard Endotracheal TubeHospitech Respiration, Ltd.20103—
+1K090352Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesCovidien20096—
+2K172208NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded StyletNevap, Inc.20180—
+2K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd.20162—
+2K120985Kimvent Microcuff Subglottic SuctioningKimberly-Clark Corp.20121—
+2K110269Well Lead Endotracheal Tube with Evacuation Lumen-OralWell Lead Medical Co., Ltd.20112Class I
+3K190878Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and…Salter Labs, Inc.20200—
+3K182739Endotracheal Tube with Evacuation LumenWell Lead Medical Co., Ltd.20190—
+3K180991AG 100sHospitech Respiration, Ltd.20181—
+3K131254Kimvent Microcuff Subglottic Suctioning Endotracheal TubeKimberly-Clark Corp.20130Class I
+4K221477AG100sHospitech Respiration, Ltd.20220—