510(k) Report

Devices descending from K083641

7 later devices reach Bivona Tracheostomy Tubes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172720TRACOE silcosoft Tracheostomy TubeTracoe Medical GmbH20180—
+1K142298Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard CuffCovidien20150Class I
+1K122531Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless…Covidien20122Class I
+1K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH20122—
+2K170720Portex Blue Line Ultra Paediatric Tracheosomy TubeSmiths Medical Asd, Inc.20170—
+2K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH20131—
+3K233713Pilling Tracheostomy TubesTeleflex Medical20240—