510(k) Report

Devices descending from K945513

11 later devices reach Mallinckrodt Shiley Neonatal, Pediatric, Long Pediatric Tracheostomy Tube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122531Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless…Covidien20122Class I
+1K962173Shikey Tracheostomy Tubes and AccessoriesMallinckrodt Medical19967Class I
+2K170720Portex Blue Line Ultra Paediatric Tracheosomy TubeSmiths Medical Asd, Inc.20170—
+2K150844Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult…Covidien20151Class I
+2K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult…Covidien20153Class I
+2K142298Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard CuffCovidien20150Class I
+2K062104Talking TrachEngineered Medical Systems, Inc.20070—
+2K030787Shiley Flextra Tracheostomy TubeNellcor Puritan Bennett, Inc.200301
+2K971267Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension…Mallinckrodt Medical19970—
+3K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with…Covidien, LLC20250—
+3K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien20200—