510(k) Report

Devices descending from K894614

2 later devices reach Bivona Aire-Cuf Adjustable Tracheostomy Tube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031553Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric…Arcadia Medical Corporation200312
+2K100480Rota-Trach Tracheostomy Tube Model Rota-TrachVitaltec Corporation20100—