510(k) Report

Devices descending from K962173

7 later devices reach Shikey Tracheostomy Tubes and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult…Covidien20151Class I
+1K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult…Covidien20153Class I
+1K062104Talking TrachEngineered Medical Systems, Inc.20070—
+1K030787Shiley Flextra Tracheostomy TubeNellcor Puritan Bennett, Inc.200301
+1K971267Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension…Mallinckrodt Medical19970—
+2K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with…Covidien, LLC20250—
+2K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien20200—