510(k) Report

Devices descending from K955564

5 later devices reach Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, Sterile through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K964056Rusch Ultra Tracheoflex Fenestrated Kit Cuffed,Uncuffed/ Rusch Tracheoflex Tracheostomy…Rusch Intl.19974Class I
+2K122235Rusch Tracflex Plus Tracheostomy Tube SetTeleflexmedical, Inc.20131—
+2K982128Shikani-French Speaking ValvePilling Weck Surgical19981—
+3K133173Rusch Tracflex Plus Pediatric Tracheostomy Tube SetTeleflexmedical, Inc.20140—
+3K100995Shikani Speaking ValveShikani Medical, LLC20100—