510(k) Report

Devices descending from K945406

4 later devices reach SSV Phonate (TM) Shiley Speaking Valve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961449Tracheostomy Tubes Tracoe-FlexTracoe Medical GmbH19963—
+2K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH20131—
+2K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH20122—
+3K233713Pilling Tracheostomy TubesTeleflex Medical20240—