510(k) Report

Devices descending from K944451

3 later devices reach Passy-Muir Tracheostomy Speaking Valves (One-Way Tracheostomy Speaking Valves) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013728Trach VoxEngineered Medical Systems20020—
+1K982128Shikani-French Speaking ValvePilling Weck Surgical19981—
+2K100995Shikani Speaking ValveShikani Medical, LLC20100—