510(k) Report

Devices descending from K922665

5 later devices reach Bivona Hyperflex Tracheostomy Tube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051587Tracoe-Vario Tracheostomy Tubes (Various) Reference Models: 450, 455, 460, 465, 470Tracoe Medical GmbH20054—
+2K203362TRACOE varioTracoe Medical GmbH20210—
+2K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH20122—
+3K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH20131—
+4K233713Pilling Tracheostomy TubesTeleflex Medical20240—