510(k) Report

Devices descending from K862267

6 later devices reach Fome-Cuf and Aire Cuf Tracheostomy Tubes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031553Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric…Arcadia Medical Corporation200312
+1K961449Tracheostomy Tubes Tracoe-FlexTracoe Medical GmbH19963—
+2K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH20131—
+2K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH20122—
+2K100480Rota-Trach Tracheostomy Tube Model Rota-TrachVitaltec Corporation20100—
+3K233713Pilling Tracheostomy TubesTeleflex Medical20240—