510(k) Report

Devices descending from K122531

2 later devices reach Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170720Portex Blue Line Ultra Paediatric Tracheosomy TubeSmiths Medical Asd, Inc.20170—
+1K142298Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard CuffCovidien20150Class I