510(k) Report

Devices descending from K871204

16 later devices reach Cuffed Tracheal Tube (Multiple) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112915Spirtius Cuff Inflation SyringeSpiritus Technologies, LLC20120—
+1K090352Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesCovidien20096—
+1K082520Sealguard Evac Endotracheal and Endotracheal TubesMallinckrodt Medical2008112
+1K031794Endoflex Tracheal TubeMerlyn Associates, Inc.20041—
+1K971267Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension…Mallinckrodt Medical19970—
+2K172208NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded StyletNevap, Inc.20180—
+2K120985Kimvent Microcuff Subglottic SuctioningKimberly-Clark Corp.20121—
+2K110269Well Lead Endotracheal Tube with Evacuation Lumen-OralWell Lead Medical Co., Ltd.20112Class I
+2K093126Anapnoguard Endotracheal TubeHospitech Respiration, Ltd.20103—
+2K080339Medsource Endotracheal Tube (with and Without Cuff)Medsource International, LLC20080—
+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—
+3K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd.20162—
+3K131254Kimvent Microcuff Subglottic Suctioning Endotracheal TubeKimberly-Clark Corp.20130Class I
+4K180991AG 100sHospitech Respiration, Ltd.20181—
+5K221477AG100sHospitech Respiration, Ltd.20220—